Status:
UNKNOWN
Fosmidomycin and Azithromycin for Acute Uncomplicated Plasmodium Falciparum Malaria (P. Malaria) in Adults
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 azithromycin as a possible combination partner for fosmidomycin to protect it from its susceptibility to recrudescent infections when used as monothera...
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 ≤ 18.5 kg/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 \> 125 umol/L or 3 mg/dl), haemoglobin \< 8g/dl, white cell count \> 12000/uL
- anti-malarial treatment within previous 28 days
- symptomatic AIDS
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01464125
Start Date
November 1 2008
End Date
December 1 2011
Last Update
November 3 2011
Active Locations (1)
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1
Mahidol University
Bangkok, Thailand, 10400