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Sponsors and Collaborators: |
Centers for Disease Control and Prevention Food and Drug Administration (FDA) Ministry of Health, Madagascar Ministry of Health, Uganda |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00128466 |
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.
Condition | Intervention | Phase |
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Plague |
Drug: gentamicin Drug: streptomycin |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 Pestis |
Estimated Enrollment: | 200 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | September 2007 |
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 of plague using serum, bubo aspirate, sputum, and urine specimens that will have already been collected from the patients enrolled in the drug trial. These rapid tests have been developed by several American companies and the Institut Pasteur in Madagascar, and have not been fully evaluated for use with human specimens. These results will be compared to standard diagnostic techniques. Such rapid diagnostic tests will be useful for plague diagnosis in developing nations and during bioterrorism events.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have a fever of at least 38 °C that developed rapidly, and have one of the following:
Exclusion Criteria:
Contact: Kevin Griffith, MD, MPH | 970-221-6400 | |
Contact: Martin Schriefer, PhD | 970-221-6400 |
Madagascar | |
Ministry of Health | Recruiting |
Antananarivo, Madagascar | |
Contact: Chris Dunston chrisdunston@wanadoo.mg | |
Principal Investigator: Chris Dunston |
Principal Investigator: | Kevin Griffith, MD, MPH | Centers for Disease Control and Prevention |
Principal Investigator: | Martin Schriefer, PhD | Centers for Disease Control and Prevention |
Study ID Numbers: | CDC-NCID-3700 |
Study First Received: | August 9, 2005 |
Last Updated: | July 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00128466 |
Health Authority: | United States: Food and Drug Administration |
bubonic plague pneumonic plague septicemic plague Yersinia pestis Pasteurella pestis |
Bacterial Infections Enterobacteriaceae Infections Gentamicins |
Streptomycin Plague Gram-Negative Bacterial Infections |
Protein Synthesis Inhibitors Anti-Infective Agents Anti-Bacterial Agents Yersinia Infections |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |