Injection Of Penicillin Research Articles

Staphylococcus epidermidis is involved in a mechanism for female reproduction in mice.

Both external and internal surfaces of organs (e.g., skin, mouth, gut, and intestine) are covered with bacteria, which often contribute to physiological events in host animals. Despite externally opened organs, the presence of bacteria in the mammalian female reproductive tract is uncertain. Here we assessed this problem using wild-type strains of mice, C57BL/6N and ICR. We first demonstrated that bacterial colonies were formed from the oviductal fluid in the C57BL/6N mice with birth experience (“parous”), but not in the mice without birth experience (“non-parous”). Sequence analysis of 16S ribosomal RNA (rRNA) revealed that Staphylococcus epidermidis existed in the oviductal fluid of the parous mice, confirmed by immunohistochemical analysis. Furthermore, extinction of bacterial population with intraperitoneal injection of antibiotics, penicillin G and streptomycin, disturbed the regularly implanted pattern of embryos in ICR mice. Our results indicate that symbiotic S. epidermidis plays a role in interaction between embryo and uterus upon implantation in mice.

Letter to the editor about Maculopapular Rash after Penicillin Injection in a Patient with Confirmed Infectious Mononucleosis.

Dear Editor We read your journals and other journals that have reported maculopapular rash developed in patients with Infectious Mononucleosis (IM) after taking antibiotics, such as Ampicillin, Amoxicillin, Minocycline, Azithromycin and Clindamycin [1,2]. But we want to explain another antibiotic which is Penicillin that caused maculopapular rash in an 18-year-old female with confirmed infectious mononucleosis. To our knowledge, there is no reported case in the literature about penicillin induced rash in infectious mononucleosis. The skin rashes developed about a week after the administration of antibiotics and usually have improved up to three months later [3]. Infectious mononucleosis is caused by Epstein-Barr Virus & kissing is the main way of transmitting the primary EBV infection. For this reason it is sometimes called “kissing disease” [4]. The laboratory tests to diagnose this disease are IgM, IgG, PCR (Polymease Chain Reaction) and widely by Monospot Test [5]. The patient that we were talking about developed rashes two days after she had received penicillin. At first we thought that the rashes can be the result of drug sensitivity. But after studying the lab results and clinical symptoms Infectious mononucleosis was confirmed. We used the Naranjo ADR (Adverse Drug Reaction) possible score [Table/Fig-1]. [Table/Fig-1]: The Naranjo adverse drug reaction score The mechanism of rash appearance in patients with infectious mononucleosis is not clearly understood. It seems that in some cases, rash development is a non-immunological response. One theory is that, the skin rash may be due to immune response as a result of the EBV presence or because of changes in pharmaceutical metabolism caused by the disease [2]. It is believed that, the immune response due to presence of the virus, is the main cause of skin rash during concurrent treatment with antibiotics. Finally, it is recommended penicillin skin test be performed, if penicillin injection is mandatory in future. Sincerely.

Accidental Intra-Arterial Injection during Test Dose of Injection of Benzyl Penicillin: Complications and Management—A Case Report

An 18 years old female patient was given a test dose of Benzyl penicillin in the Antecubital Area on the right forearm by a staff nurse of the department. After the injection, the patient complained of severe pain in the right forearm distal to the injection site. This was followed by blanching of the right forearm and hand. She was immediately heparinised followed by other symptomatic treatments. After 12 hours, a bluish discoloration developed on the hand, both on dorsal and palmar aspect, sparing the thumb. This recovered with medication, except the late development of dry gangrene of the tip of distal phalanx of the little finger which got shrivelled later on. Color Doppler flow study, echocardiography, and CT angiography of the right upper limb were done. Understanding of the pathogenesis and prompt action can help in saving a limb. Education of the medical professionals involved in administering injection is necessary so that they become aware of abnormal course or anomalous anatomy of vessels of upper limb. This can help to prevent the complications.

Applying Manual Pressure before Benzathine Penicillin Injection for Rheumatic Fever Prophylaxis Reduces Pain in Children

The purpose of this study was to evaluate the efficacy of applying manual pressure before benzathine penicillin injection and compare it with the standard injection technique in terms of reducing discomfort in children with rheumatic heart disease grouped by age and gender. This was a single-blind, randomized, crossover study. Fifty-one patients aged 7.1-19.9 years were recruited for this study carried out in the pediatric cardiology outpatient clinic. Twenty-nine were girls (56.9%). All subjects received an intramuscular injection of benzathine penicillin with manual pressure to one buttock or with the standard technique to the other buttock at 3-week intervals. The two techniques were used randomly. The subjects were blinded to the injection technique and a visual analogue scale was used after the procedure. Findings demonstrate that children experienced significantly less pain when they received injections with manual pressure (1.3 ± 0.9) compared with the standard injection (4.4 ± 1.6) technique. The perceived injection pain was negatively related to the age of the children in both techniques. Compared with boys, girls felt more pain, but the difference between each technique group according to gender was negligible. The application of manual pressure reduces pain in children under the stress of repeated intramuscular injections, which supports the suggestion that it should be used in routine practice. Manual pressure to the injection site is a simple, pain-reducing technique. Implementing this technique in routine practice may also promote adherence to the prophylaxis regimen, especially in children.

Effect of subthalamic nucleus stimulation on penicillin induced focal motor seizures in primate.

Drug-resistant motor epilepsies are particularly incapacitating for the patients. In a primate model of focal motor seizures induced by intracortical injection of penicillin, we recently showed that seizures propagated from the motor cortex towards the basal ganglia. Using the same animal model here, we hypothesized that disruption of subthalamic nucleus (STN) activity by chronic high frequency stimulation (HFS) could modify pathological excessive cortical synchronisation occurring during focal motor seizures, and therefore could reduce seizure activity. Two monkeys were chronically implanted with one electrode positioned into the STN. In each experiment, seizures were induced during 6 hours by injecting penicillin into the motor cortex. During stimulation sessions, HFS-STN was applied at the beginning of penicillin injection. Our results indicate that HFS-STN improved focal motor seizures by delaying the occurrence of the first seizure, by decreasing the number of seizures by 47% and therefore the total time spent seizing by 53% compared to control. These results argue for a therapeutic use of HFS-STN in motor seizures because they were obtained in a very severe primate model of motor status similar to that seen in human. Furthermore, HFS-STN was much more efficient than direct cortical HFS of the epileptic focus, which we already tested in the same primate model. The present study suggests that HFS-STN could be used as an experimental therapy when other therapeutic strategies are not possible or have failed in humans suffering from motor epilepsy but the present study still warrants controlled studies in humans.

Effect of levetiracetam on penicillin induced epileptic activity in rats.

The aim of this study was to investigate the effects of levetiracetam (LEV) on penicillin-induced epileptiform activity in rats. Penicillin was applied intracerebroventricularly (icv) at a dose of 500 IU to induce epileptiform activity. LEV was given intraperitoneally (ip) at doses of 20, 40, 80 mg/kg before penicillin injection. This agent reduced epileptiform activity by decreasing spike frequencies. The mean spike frequencies decreased significantly in all the LEV treated groups. There was no significant change in the spike amplitudes of the LEV groups compared with the control group. 40 mg/kg of LEV was determined as the most effective dose on reducing epileptiform activity. The results of this study suggest that LEV is an effective antiepileptic agent in penicillin-induced epilepsy.

Eradication of yaws: historical efforts and achieving WHO's 2020 target.

BackgroundYaws, one of the 17 neglected tropical diseases (NTDs), is targeted for eradication by 2020 in resolution WHA66.12 of the World Health Assembly (2013) and the WHO roadmap on NTDs (2012). The disease frequently affects children who live in poor socioeconomic conditions. Between 1952 and 1964, WHO and the United Nations Children's Fund (UNICEF) led a global eradication campaign using injectable benzathine penicillin. Recent developments using a single dose of oral azithromycin have renewed optimism that eradication can be achieved through a comprehensive large-scale treatment strategy. We review historical efforts to eradicate yaws and argue that this goal is now technically feasible using new tools and with the favorable environment for control of NTDs. We also summarize the work of WHO's Department of Control of Neglected Tropical Diseases in leading the renewed eradication initiative and call on the international community to support efforts to achieve the 2020 eradication goal. The critical factor remains access to azithromycin. Excluding medicines, the financial cost of yaws eradication could be as little as US$ 100 million.ConclusionsThe development of new tools has renewed interest in eradication of yaws; with modest support, the WHO eradication target of 2020 can be achieved.

More than meets the eye: Monocular syphilis in an HIV-negative patient

A 50-year old heterosexual male presented with discomfort in his left eye and abnormal behavior. Physical examination showed a red eye suggestive of uveitis. He was found to have a reactive rapid plasma reagin (RPR) test in high titer and a cerebrospinal fluid (CSF) pleocytosis, with a reactive Venereal Disease Research Laboratory (VDRL) titer in the CSF. Testing for human immunodeficiency virus (HIV)-1 and HIV-2 was negative. He was diagnosed with ocular/neurosyphilis and treated with intravenous (IV) penicillin G for 14 days followed by an intramuscular injection of benzathine penicillin, with complete resolution of ocular findings and behavioral changes. This report illustrates an unusual presentation of ocular/neurosyphilis in an HIV-negative i

Electrophysiological evidence on epileptiform activity enhanced by electrical stimulation of teeth in rats

The aim of this study was to evaluate the possible effects of electrical stimulation (ES) of tooth on penicillin-induced epileptiform activity in rats.Experiment was realized on 24 adult male Sprague Dawley rats. Rats were assigned three groups [stimulation group (SG), penicillin group (PG), and penicillin+stimulation group (PSG)]. In SG, ES was only applied. Ten pulses of electrical current were delivered to the teeth for a duration of 2 milliseconds at 1-second intervals from a stimulator. Currents were applied in the range of 40–240 μA with 40 μA steps. Electrocorticography (ECoG) recordings were taken before and after ES. In PG, ECoG recordings were taken before and during the injection of penicillin. In PSG, after epileptiform activity was induced, ES was applied and ECoG recordings were taken as in SG. All the data were analyzed with Student’s t test. Applied currents did not cause any epileptiform activity in SG. When the PSG was compared with the PG it was seen that the spike frequency of epileptiform activity increased in a statistically significant way after application of 240 μA (P < 0·05). On the other hand current application caused an increase in the spike amplitude of the PSG compared with the amplitude of the PG, but it was not statistically significant.We concluded that ES of tooth with high current can trigger epileptiform activity in rats. For this reason, further research is required to evaluate the effects of ES of tooth for pulp testing on epileptic human subjects and antiepileptic drug users.

English

INTRODUCTION: Pseudomonas aeruginosa is an aerobic, motile, gram negative rod that belongs to the family, pseudomonadaceae 2 . Its general resistance is due to a combination of factors 3 .Regional variations in the antibiotic resistance exist for different organisms, including P. aeruginosa and this may be related to the difference in the antibiotic prescribing habits. So, we aimed in the present study, to determine the status of antimicrobial resistance to anti- pseudomonadal agents and the magnitude of the multidrug resistance in these organisms.MATERIALS AND METHODS: This study was conducted during 1 st January 2013 to 30 th September 2013. During this period total of 5877 samples were tested, out of 5877 samples, 1693 samples showed growth on culture and out of 1693 samples, 152 Pseudomonas aeruginosa were isolated. Identification & sensitivity of all isolates were done by BD PhoenixTM Automated Microbiological System. The antibiotics which were included in the panel were ciprofloxacin, levofloxacin, gentamicin, amikacin, tobramycin, aztreonam, ceftazidime, cefepime, piperacillin, piperacillin/tazobactam, ticarcillin/tazobactam, imipenem, meropenem and colistinaccording to CLSIs guidelines.RESULT: In the present study, the highest numbers of Pseudomonas infections was found in pus followed by urine and Endotracheal secretion. Pseudomonas aeruginosa isolated from various samples were resistant to aztreonam, ciprofloxacin followed by levofloxacin, ceftazidime, cefepime, amikacin, imipenem & colistin.CONCLUSION: To prevent the spread of the resistant bacteria, it is critically important to have strict antibiotic policies wherein surveillance programmes for multidrug resistant organisms and infection control procedures need to be implemented. INTRODUCTION: Antibiotic when first introduced was considered as a magic bullet. A single injection of penicillin could eradicate a life threatening infection. Unfortunately with time due to malpractices, most of the cheaper antibiotics have lost their efficacy and more and more expensive and complicated antibiotics were introduced and marketed to combat simple infection1. The microbial pathogens, as well as, their antibiotic sensitivity pattern, may change from time to time and place to place. Therefore knowledge of current drug resistance pattern of the common pathogenic bacteria in a particular region is useful in clinical practice. Pseudomonas aeruginosa is an aerobic, motile, gram negative rod that belongs to the family, pseudomonadaceae2. Its general resistance is due to a combination of factors3. It is intrinsically resistant to antimicrobial agents, due to the low permeability of its cell wall. It has the genetic capacity to express a wide repertoire of resistance mechanisms. It can become resistant through mutations in the chromosomal genes which regulate the resistance genes. It can acquire additional resistance genes from other organisms via plasmids, transposons and bacteriophages. In recent years, a considerable increase in the prevalence of multidrug resistance (MDR) in P. aeruginosa has been noticed, leading to high morbidity and mortality4, 5.

Characteristics of a primate model of focal motor cortical seizures suitable for preclinical testing of therapies like DBS

Background and objective: Generating and characterizing primate models of epileptic seizures are important for understanding pathophysiology of diseases and establishing preclinical efficacy of novel therapies like Deep Brain Stimulation. A focal motor epilepsy model is described here. Method: Seizures were obtained after intracortical penicillin injection into the motor strip through a cannula in two awake monkeys and electrocorticograms were recorded by epidural screws. Seizures were analyzed and compared for number, average duration of each seizure and total duration of ictal activity. Pharmaco-resistance for antiepileptic drug was tested by administration of Diazepam during seizures. Results: A motor status with seizures mimicking those seen in Kojevnikov’s syndrome was easily generated several minutes after penicillin injection and lasted 24 h on an average. The model thus characterized appears stable and consistent. There is no significant variation between experiments in individual primate as well as between two specimens. Diazepam though reduced the total duration of seizures, failed to abolish behavioural seizures. Conclusion: This model represents a good alternative model for preclinical research aiming at testing novel therapies because seizures are obtained on demand, last up to 24 h after a single penicillin injection, are stable and resistant to Diazepam.

Anaphylactic Shock after Intravenous Injection of Penicillin in a Patient with Maxillary Osteonecrosis: Report of a Case

Anaphylactic Shock after Intravenous Injection of Penicillin in a Patient with Maxillary Osteonecrosis: Report of a Case

Mandibular Fibrosarcoma and Bile Duct Adenoma in a Pet Rabbit (&amp;lt;i&amp;gt;Oryctolagus cuniculi&amp;lt;/i&amp;gt;): A Case Report

This report describes the clinical manifestations and pathological findings in a 4-year-old neutered male dwarf rabbit diagnosed with a mandibular fibrosarcoma. The rabbit was evaluated for a unilateral mandibular swelling and an acute onset of oral blood loss. Physical examination confirmed a marked facial asymmetry with a swollen painful left mandible. Radiographic projections of the skull revealed a left mandibular mass extending into the oral cavity. Tissue biopsies demonstrated severe bone destruction and a presumptive pathological diagnosis of a mandibular osteosarcoma were made. A helical CT (computed tomography) study of the skull confirmed the severe mandibular bone destruction and the oral extension of the mass. The patient was treated palliative with oral meloxicam and subcutaneous penicillin injections. Six months later, the rabbit died in a natural way. Postmortem examination led to final diagnosis of severe left facial malformation due to mandibular fibrosarcoma. A bile duct adenoma was found in the liver. To the author’s knowledge, this is the first description of a spontaneous mandibular fibrosarcoma in a pet rabbit.

Improvement in rheumatic fever and rheumatic heart disease management and prevention using a health centre-based continuous quality improvement approach.

BackgroundRheumatic heart disease (RHD) remains a major health concern for Aboriginal Australians. A key component of RHD control is prevention of recurrent acute rheumatic fever (ARF) using long-term secondary prophylaxis with intramuscular benzathine penicillin (BPG). This is the most important and cost-effective step in RHD control. However, there are significant challenges to effective implementation of secondary prophylaxis programs. This project aimed to increase understanding and improve quality of RHD care through development and implementation of a continuous quality improvement (CQI) strategy.MethodsWe used a CQI strategy to promote implementation of national best-practice ARF/RHD management guidelines at primary health care level in Indigenous communities of the Northern Territory (NT), Australia, 2008–2010. Participatory action research methods were employed to identify system barriers to delivery of high quality care. This entailed facilitated discussion with primary care staff aided by a system assessment tool (SAT). Participants were encouraged to develop and implement strategies to overcome identified barriers, including better record-keeping, triage systems and strategies for patient follow-up. To assess performance, clinical records were audited at baseline, then annually for two years. Key performance indicators included proportion of people receiving adequate secondary prophylaxis (≥80% of scheduled 4-weekly penicillin injections) and quality of documentation.ResultsSix health centres participated, servicing approximately 154 people with ARF/RHD. Improvements occurred in indicators of service delivery including proportion of people receiving ≥40% of their scheduled BPG (increasing from 81/116 [70%] at baseline to 84/103 [82%] in year three, p = 0.04), proportion of people reviewed by a doctor within the past two years (112/154 [73%] and 134/156 [86%], p = 0.003), and proportion of people who received influenza vaccination (57/154 [37%] to 86/156 [55%], p = 0.001). However, the proportion receiving ≥80% of scheduled BPG did not change. Documentation in medical files improved: ARF episode documentation increased from 31/55 (56%) to 50/62 (81%) (p = 0.004), and RHD risk category documentation from 87/154 (56%) to 103/145 (76%) (p < 0.001). Large differences in performance were noted between health centres, reflected to some extent in SAT scores.ConclusionsA CQI process using a systems approach and participatory action research methodology can significantly improve delivery of ARF/RHD care.

Antenatal syphilis screening using point-of-care testing in Sub-Saharan African countries: a cost-effectiveness analysis.

Untreated syphilis in pregnancy is associated with adverse clinical outcomes for the infant. Most syphilis infections occur in sub-Saharan Africa (SSA), where coverage of antenatal screening for syphilis is inadequate. Recently introduced point-of-care syphilis tests have high accuracy and demonstrate potential to increase coverage of antenatal screening. However, country-specific cost-effectiveness data for these tests are limited. The objective of this analysis was to evaluate the cost-effectiveness and budget impact of antenatal syphilis screening for 43 countries in SSA and estimate the impact of universal screening on stillbirths, neonatal deaths, congenital syphilis, and disability-adjusted life years (DALYs) averted. The decision analytic model reflected the perspective of the national health care system and was based on the sensitivity (86%) and specificity (99%) reported for the immunochromatographic strip (ICS) test. Clinical outcomes of infants born to syphilis-infected mothers on the end points of stillbirth, neonatal death, and congenital syphilis were obtained from published sources. Treatment was assumed to consist of three injections of benzathine penicillin. Country-specific inputs included the antenatal prevalence of syphilis, annual number of live births, proportion of women with at least one antenatal care visit, per capita gross national income, and estimated hourly nurse wages. In all 43 sub-Saharan African countries analyzed, syphilis screening is highly cost-effective, with an average cost/DALY averted of US$11 (range: US$2-US$48). Screening remains highly cost-effective even if the average prevalence falls from the current rate of 3.1% (range: 0.6%-14.0%) to 0.038% (range: 0.002%-0.113%). Universal antenatal screening of pregnant women in clinics may reduce the annual number of stillbirths by up to 64,000, neonatal deaths by up to 25,000, and annual incidence of congenital syphilis by up to 32,000, and avert up to 2.6 million DALYs at an estimated annual direct medical cost of US$20.8 million. Use of ICS tests for antenatal syphilis screening is highly cost-effective in SSA. Substantial reduction in DALYs can be achieved at a relatively modest budget impact. In SSA, antenatal programs should expand access to syphilis screening using the ICS test. Please see later in the article for the Editors' Summary.

Integration of Preventing Mother-To-Child Transmission of HIV and Syphilis Testing and Treatment in Antenatal Care Services in the Northern Cape and Gauteng Provinces, South Africa

South Africa recommends universal syphilis and HIV testing in pregnancy, with prompt antiretroviral therapy or penicillin treatment for women testing positive. We used a multistage, purposeful sampling strategy to retrospectively identify clinical records from a sample (7.3%) of 32,518 women delivering from January 2005 to June 2006 at 6 public clinics in the Northern Cape and Gauteng. Descriptive analyses and logistic regression were used to assess coverage and factors related to testing and treatment of HIV and syphilis. Of 2379 women sampled, 93% accessed antenatal care (ANC) services during pregnancy and 71% before the third pregnancy trimester. Testing during pregnancy or delivery was 74% for HIV and 84% for syphilis; testing at the first ANC visit was 41% and 71%; and infection prevalence at delivery was 14% and 5%, respectively. Of 243 women with reactive HIV tests, 104 (43%) had treatment documented (single-dose nevirapine) before delivery. Of 98 women with reactive syphilis tests, 73% had documented receipt of 1 penicillin injection and 36% had all 3 recommended injections. Multivariable analysis found women tested for syphilis were almost 4 times more likely to have had no HIV test compared with those without syphilis testing (adjusted odds ratios, 3.9; 95% confidence interval, 1.7-5.5). Integration and provision of a package of HIV and syphilis testing at the first ANC visit and decentralizing treatments of both infections to primary care settings could increase the coverage of testing and treatment services, thus enhancing the effectiveness of current programs eliminating mother-to-child transmission of HIV and syphilis.

Reducing the pain of intramuscular benzathine penicillin injections in the rheumatic fever population of Counties Manukau District Health Board

To evaluate the effectiveness of lignocaine and a vibrating device with cold pack (Buzzy) for pain management of intramuscular (IM) benzathine penicillin injections in the rheumatic fever (RF) population of Counties Manukau District Health Board (CMDHB). Four hundred and five RF patients receiving four weekly injections in the CMDHB region were offered 0.25 mL of lignocaine 2% and Buzzy for pain management of their injections. The lignocaine was mixed in with the benzathine penicillin prior to administration. A pre and post survey assessed pain scores during, 2-min and 1-h post administration and the following day. Questions assessing fear were also included. In total 49% of patients responded to the survey. There were 118 surveys paired pre and post intervention. Pain at injection delivery and fear scores were higher for participants ≤13 years of age. Overall pain scores were significantly reduced over all four time points. There was also a significant reduction in fear of the injections. Lignocaine and Buzzy resulted in a greater reduction in pain than lignocaine alone, only when the injection was being administered to those ≤13 years. After five months, a file audit showed that 66% of all RF patients of CMDHB were choosing to use lignocaine and 43% were choosing to use Buzzy. In total, 71% of all RF patients were choosing one or both of these analgesic interventions. This study demonstrates a clinically important reduction in the subjective experience of pain when two analgesic interventions were offered with IM delivery of benzathine penicillin. These pain reduction strategies have been popular in the RF population of CMDHB with a 71% uptake and a corresponding reduction in pain and fear.

Effect on pain intensity of injection sites and speed of injection associated with intramuscular penicillin

The aim of this one-group, quasi-experimental study was to examine the effect of choice of injection site and injection duration on the intensity of pain associated with intramuscular penicillin injection. Injections containing the same dose of drug were administered 12 hours apart for each patient over 5 s/mL and 10 s/mL durations in the dorsogluteal and ventrogluteal sites. Sixty patients who had a medical order for intramuscular penicillin at least twice in a day and for two successive days at the same dose were included in the study. No difference in pain was perceived by participants between the two injection durations at either the dorsogluteal or the ventrogluteal site. This study showed that intramuscular penicillin can be administered to either site over 5 s/mL or 10 s/mL durations. There is a need for further research with a randomized controlled design in different settings and in a larger sample on the impact of choice of injection site and injection duration on pain intensity.

Scientific Rationale for Study Design of Community-based Simplified Antibiotic Therapy Trials in Newborns and Young Infants With Clinically Diagnosed Severe Infections or Fast Breathing in South Asia and sub-Saharan Africa

Background:Newborns and young infants suffer high rates of infections in South Asia and sub-Saharan Africa. Timely access to appropriate antibiotic therapy is essential for reducing mortality. In an effort to develop community case management guidelines for young infants, 0–59 days old, with clinically diagnosed severe infections, or with fast breathing, 4 trials of simplified antibiotic therapy delivered in primary care clinics (Pakistan, Democratic Republic of Congo, Kenya and Nigeria) or at home (Bangladesh and Nigeria) are being conducted.Methods:This article describes the scientific rationale for these trials, which share major elements of trial design. All the trials are in settings of high neonatal mortality, where hospitalization is not feasible or frequently refused. All use procaine penicillin and gentamicin intramuscular injections for 7 days as reference therapy and compare this to various experimental arms utilizing comparatively simpler combination regimens with fewer injections and oral amoxicillin.Conclusion:The results of these trials will inform World Health Organization policy regarding community case management of young infants with clinical severe infections or with fast breathing.

Treatment of fast breathing in neonates and young infants with oral amoxicillin compared with penicillin-gentamicin combination: study protocol for a randomized, open-label equivalence trial.

Background:The World Health Organization recommends hospitalization and injectable antibiotic treatment for young infants (0–59 days old), who present with signs of possible serious bacterial infection. Fast breathing alone is not associated with a high mortality risk for young infants and has been treated with oral antibiotics in some settings. This trial was designed to examine the safety and efficacy of oral amoxicillin for young infants with fast breathing compared with that of an injectable penicillin–gentamicin combination. The study is currently being conducted in the Democratic Republic of Congo, Kenya and Nigeria.Methods/Design:This is a randomized, open-label equivalence trial. All births in the community are visited at home by trained community health workers to identify sick infants who are then referred to a trial study nurse for assessment. The primary outcome is treatment failure by day 8 after enrollment, defined as clinical deterioration, development of a serious adverse event including death, persistence of fast breathing by day 4 or recurrence up to day 8. Secondary outcomes include adherence to study therapy, relapse, death between days 9 and 15 and adverse effects associated with the study drugs. Study outcomes are assessed on days 4, 8, 11 and 15 after randomization by an independent outcome assessor who is blinded to the treatment being given.Discussion:The results of this study will help inform the development of policies for the treatment of fast breathing among neonates and young infants in resource-limited settings.