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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborators:
Food and Drug Administration (FDA) Ministry of Health, Madagascar Ministry of Health, Uganda