Malaria, Vivax Clinical Trial
Official title:
Pilot Human Study of Tinidazole Efficacy For Radical Cure Of Plasmodium Vivax
Assess the efficacy of 2 grams of tinidazole given for 5 days with standard dose chloroquine to achieve radical cure of Plasmodium vivax within a 90 day follow-up period sufficient to justify an IND and formal phase II evaluation.
This is a randomized, open-label study that will treat adult subjects with Plasmodium vivax
infection with chloroquine for 3 days and tinidazole for 5 days concomitantly to assess
efficacy for radical cure (clearance of blood and liver stages of infection). There will be
randomization to a positive comparator arm treated with chloroquine and primaquine
(definitive radical cure) in order to obtain an estimate of the rate of re-infection during
the monitoring period in the study population.
A simple randomization procedure will assign subjects to one of the two arms (treatment arm
or comparator arm). The ratio of assignment will be 2:1, treatment arm to the comparator
arm. The exact number assigned to the treatment arm will vary depending on the initial
outcome of early enrollees per the sequential analysis design of the trial. In the worse
case scenario of no clear trend developing early, no more than 50 subjects will be required
to complete the trial in the study drug arm in order to arrive at a conclusion regarding the
study drug.
Follow-up period will be for 90 days. This will allow us to capture essentially all early
relapses that would occur under normal circumstances, as well as assess if tinidazole may
delay but not fully eliminate recurrence. Subjects without a recurrence at 90 days will be
considered to have achieved radical cure.
This study will use a modified triangular test, a form of sequential analysis designed to
enable repeated statistical analyses throughout the study recruitment period, while
maintaining a pre-specified power and type I error. The trial can be stopped as soon as the
information accumulated is considered sufficient to reach a conclusion and it will limit
enrollment and exposure to a failing treatment regimen.
Results of this study will be sufficient to determine whether tinidazole should be
designated as an "early kill" (an ineffective drug for vivax malaria radical cure with no
future evaluation) or whether it is sufficiently efficacious to warrant further investment
with an IND and formal phase II study to seek an SNDA.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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