Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128466
Status:
COMPLETED
Last Update Posted:
2009-02-26
First Post:
2005-08-09
Brief Title:
Treatment and Diagnosis of Plague
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 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 be compared to the standard drug regimen that is already used in Madagascar streptomycinco-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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None