Clinical Trial: Treatment and Diagnosis of Plague
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Efficacy of Gentamicin Versus Streptomycin for the Treatment of Naturally Occurring Human Plague and Evaluation of Rapid Diagnostic Test Kits for Yersinia Pesti
Brief Summary:
This clinical trial will compare the effectiveness of streptomycin, which historically is the standard drug for treatment of plague, with gentamicin. The hypothesis is that gentamicin is not inferior to streptomycin but that it will have less severe side effects. The study is being done in Madagascar because that country reports the most plague cases in the world. Patients coming into a participating clinic with suspected plague (bubonic, pneumonic, or septicemic) will be randomized into one of two treatment arms after giving informed consent. Patients will be monitored for side effects and for improvement of symptoms.
In addition, rapid diagnostic test strips have been developed but not fully evaluated for use on humans. The investigators will evaluate these new tests on specimens from the same patients, comparing their performance with that of classical diagnostic methods such as culture and serology.
Detailed Summary:
This protocol will guide clinical trials of treatment of naturally occurring human plague cases in African countries with a high incidence of human plague. The safety and efficacy of gentamicin will be compared to the standard drug regimen that is already used in Madagascar (streptomycin/co-trimoxazole) for treatment of plague. Data from this trial will be valuable to optimize clinical management of plague in many countries, including Madagascar and the United States.
In collaboration with the governments and health officials of Madagascar, the investigators will implement a randomized, controlled, non-blinded drug trial to compare the effectiveness and side effect profile of gentamicin to the national standard plague treatment.
Cases of plague will be identified through clinic-based surveillance in areas with a high incidence and/or in areas that have experienced outbreaks in recent years. After giving informed consent, patients will be randomly assigned to one of two treatment arms, each arm receiving a different antimicrobial. One patient group will be treated with gentamicin; the other group ("control group") will receive streptomycin alone or with co-trimoxazole.
This protocol will follow the national guideline of the Madagascar Ministry of Health, which means that patients with bubonic plague in the streptomycin treatment arm will receive streptomycin followed by trimethoprim-sulfamethoxazole. The only adaptation is that enrolled patients with renal insufficiency will receive adjusted dosing of streptomycin, whereas the national standard treatment does not call for dose adjustment in renal failure.
The investigators will also evaluate several newly available, rapid "dipstick" tests for the diagnosis
Sponsor: Centers for Disease Control and Prevention
Current Primary Outcome: Survival or death at 2 weeks
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to defervescence during treatment
- Number and severity of adverse effects at 2 weeks
- Complications at 2 weeks
Original Secondary Outcome: Same as current
Information By: Centers for Disease Control and Prevention
Dates:
Date Received: August 9, 2005
Date Started: August 2004
Date Completion:
Last Updated: February 24, 2009
Last Verified: February 2009
