Clinical Trials Focusing on Drug Control and Prevention of Ventilator-Associated Pneumonia: A Comprehensive Analysis of Trials Registered on ClinicalTrials.gov.

Lingmin Chen,Liuliu Quan,Liang Du,Yanling Su,Yonggang Zhang

doi:10.3389/fphar.2018.01574

Abstract

Objective: Clinical trials have emerged as the main force in driving the development of medicine. However, little is known about the current status of clinical trials regarding drug control and prevention of ventilator-associated pneumonia (VAP). This study aimed at providing a comprehensive landscape of these trials on the basis of ClinicalTrials.gov.Methods: A cross-sectional, descriptive study of clinical trials on drug control and prevention of VAP which have been registered on the ClinicalTrials.gov up to 25th August 2018 was conducted.Results: A total of 109 eligible trials were identified. Trials were started from 1998 to 2018, and most trials focused on adult patients. More than half trials were completed, while only 11.9% trials had results available. Sample sizes were relatively large, with a median enrollment of 146. Universities were listed as the primary sponsor for 36.7% trials, industry for 28.4% trials and hospitals for 19.3% trials. Of the 109 VAP trials, 37 trials were from in Europe, 36 in North America and 27 in Asia. Among the 97 interventional trials, 32 were phase 3 trials, 21 were phase 4 trials, and 16 were phase 2 trials. Most interventional trials were randomized trials with a parallel assignment, and 57.7% trials were blinded. Of the 12 observational trials, 9 were cohort studies, and 10 trials were prosepctive studies. Drugs about oral care, preemptive antibiotics and probiotics were most investigated for prevention. A total of 61 trials investigated drugs for the treatment of VAP, mainly focused on antibiotics. A total of 36 kinds of antibiotics were investigated for monotherapy or combination therapy. Beta-lactams were most studied, followed by aminoglycosides and polypeptides.Conclusion: Most clinical trials registered on ClinicalTrials.gov about drugs for VAP were interventional trials with the purpose for treatment. A high proportion of interventional trials were randomized, parallel assigned and masked. Our analysis highlights the need for improvement in completeness of study results on the ClinicalTrials.gov.

Highlights

RESULTSVentilator-associated pneumonia (VAP) is defined as nosocomial pneumonia that occurs in mechanically ventilated patients at least 48 h after the initiation of mechanical ventilation (Bassetti et al, 2012)
A cross-sectional, descriptive study of clinical trials on drug control and prevention of VAP which had been registered on the ClinicalTrials.gov database was conducted
The trials were obtained from ClinicalTrials.gov using the advanced search function with the search term “ventilator-associated pneumonia” for “condition” on August 25th, 2018

Summary

Introduction

Ventilator-associated pneumonia (VAP) is defined as nosocomial pneumonia that occurs in mechanically ventilated patients at least 48 h after the initiation of mechanical ventilation (Bassetti et al, 2012). VAP has been associated with worsened patient outcomes, increased hospitalization cost and higher mortality rates (Roberts et al, 2017). A number of evidencebased strategies have been used for the prevention and treatment of VAP (Davis, 2006; Liapikou et al, 2014). With the increase of multidrug-resistant infections, it becomes more difficult to select appropriate antibiotics for patients with VAP (Roberts et al, 2017). More efforts are needed to develop more effective prevention and treatment strategies

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Results

Conclusion