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Abstract
BackgroundAcute encephalitis syndrome (AES) is a public health problem in India. Neuroinfections are believed to be the most important etiology. Minocycline is a semisythetic tetracycline having excellent penetration into cerebrospinal fluid, established neuroprotective and antiviral properties besides action on nonviral causes of AES. It has been shown to be effective in animal model of Japanese encephalitis (JE). A randomized, controlled trial of nasogastric/oral minocycline in JE and AES at a single centre in Uttar Pradesh, northern India, was therefore conducted.MethodsPatients beyond 3 years of age - but excluding women aged 16–44 years - hospitalized with AES of < =7 days duration were enrolled and block randomized to receive nasogastric/oral minocycline or placebo suspension and followed up. Patients, study personnel and those entering data were blinded as to drug or placebo received. Primary outcome was cumulative mortality at 3 months from hospitalization. Analysis was by intention to treat.Results281 patients were enrolled, 140 received drug and 141 placebo. While there was no overall statistically significant difference in 3 month mortality between drug and placebo groups [RR = 0 · 83 (0 · 6-1 · 1)], there were encouraging trends in patients older than 12 years [RR = 0.70 (0.41-1.18)] and in Glasgow Outcome Score (GOS) at 3 months (χ2 = 7 · 44, p = 0 · 059). These trends were further accentuated if patients dying within one day of reaching hospital were excluded [OR for 3 month mortality =0 · 70 (0 · 46-1 · 07), p = 0.090; 3 month GOS p = 0 · 028].ConclusionsA trend towards better outcomes was observed with minocycline, especially in those patients who survived the initial day in hospital. These findings should form the basis for planning a larger study and possibly including minocycline in the initial management of AES as seen here.Trial registrationThe trial was registered with Clinical Trials Registry of India (CTRI) - CTRI/2010/091/006143
Highlights
Acute encephalitis syndrome (AES) is a public health problem in India
As has been seen in the past [26, 27], patients of AES had a short history of abrupt onset of fever, often with headache and vomiting
We conclude that there is a trend towards better outcomes with minocycline in AES seen here, especially in patients who survive the initial day in hospital
Summary
Acute encephalitis syndrome (AES) is a public health problem in India. A randomized, controlled trial of nasogastric/oral minocycline in JE and AES at a single centre in Uttar Pradesh, northern India, was conducted. Acute onset of fever with alteration in consciousness is an important cause of hospital admissions in large parts of India. Such a presentation is most commonly caused by invasion of the brain by an infectious agent – virus, bacteria, protozoa, rickettsiae, mycoplasma etc. Other causes include noninfectious brain inflammations, Uttar Pradesh is India’s most populous and one of its poorest states, with low human development indices [2]. Even so our hospital continues to receive 1000–1200 patients of AES annually, some of which are proven to be JE. Intravenous ceftriaxone is usually used and empirical acyclovir used occasionally
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