Status:
WITHDRAWN
Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate
Lead Sponsor:
Jomaa Pharma GmbH
Collaborating Sponsors:
Mahidol University
Thammasat University
Conditions:
Malaria
Eligibility:
All Genders
15-55 years
Phase:
PHASE2
Brief Summary
The aim of this study is to evaluate the role of clindamycin and artesunate as possible combination partners for fosmidomycin to protect it from its susceptibility to recrudescent infections when used...
Detailed Description
The scientific rationale for the use of this combination is to inhibit the ability of the parasite to synthesise isoprenoids, as precursors of many essential compounds including sterols, carotenoids a...
Eligibility Criteria
Inclusion
- male and female subjects aged 15 to 55 years
- body mass index ≥ 18.5kg/M2
- uncomplicated P falciparum malaria with acute manifestations
- asexual parasitaemia between 500uL and 100,000uL
- ability to tolerate oral therapy
- able to give informed signed consent
Exclusion
- signs of severe malaria, according to WHO criteria
- body mass index ≤ 18.5kg/M2
- pregnancy by history or by positive urine test
- lactation
- mixed plasmodial infection
- concomitant disease masking assessment of response, including diabetes,
- uncontrolled hypertension, heart failure, hepatic dysfunction (alanine-amino transferase \>150 U/L), renal impairment (creatinine \>125umol/L or 3mg/dl)
- haemoglobin \< 8g/dl
- white cell count \> 12000/uL
- anti-malarial treatment within previous 28 days
- symptomatic AIDS
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01002183
Last Update
September 27 2011
Active Locations (1)
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1
Mahidol University
Bangkok, Thailand, 10400