Status:
COMPLETED
Treatment and Diagnosis of Plague
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Food and Drug Administration (FDA)
Ministry of Health, Madagascar
Conditions:
Plague
Eligibility:
All Genders
2+ years
Phase:
PHASE2
PHASE3
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 ...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- 2 years of age or older.
- Patients must have had potential exposure to rodents and/or their fleas or contact with a known plague case.
- Patients must have a fever of at least 38 °C that developed rapidly, and have one of the following:
- One or more buboes (defined as tender lymph node swelling \>=1 cm) that appeared after or at the same time as the fever; or
- Clinical suspicion of pneumonic plague (prostration, cough, increased respiratory rate, hemoptysis and/or purulent sputum); or
- Clinical suspicion of plague AND an epidemiological link with other cases.
- Only patients that are later confirmed by standard diagnostic tests will be included in the final analysis. Patients who do not have plague confirmed by standard tests will still be included in the safety analysis.
Exclusion
- Has signs fitting plague meningitis (severely ill patient with signs of plague and one or more of the following: headache, fever, sensorial disturbances, neck and back stiffness, and/or positive Kernig and Brudzinski signs).
- Has hypotension unresponsive to fluid therapy (i.e. shock). In adults hypotension is defined as systolic blood pressure \< 80 mmHg and heart rate \> 110/min; in children it will need to be diagnosed by attending physician or medical officer.
- Has an "illness severity score" of 16 or higher (see Patient Record)
- Has a known allergy to gentamicin, streptomycin, or trimethoprim-sulfamethoxazole
- Is receiving dialysis for renal failure
- Has other severe underlying disease such as hepatic failure or other severe organ failure
- Has taken tetracyclines, quinolones, gentamicin, streptomycin, trimethoprim-sulfamethoxazole, or chloramphenicol in the last 24 hours. If the patient has taken medications that are not known, he/she will still be enrolled.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00128466
Start Date
August 1 2004
End Date
February 1 2007
Last Update
February 26 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ministry of Health
Antananarivo, Antananarivo, Madagascar