Fosmidomycin and Azithromycin for Acute Uncomplicated Plasmodium Falciparum Malaria (P. Malaria) in Adults

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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 monotherapy for acute Plasmodium falciparum malaria while retaining its excellent safety profile.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jomaa Pharma GmbH
• Collaborators: Mahidol University; Thammasat University
• Treatments: Azithromycin; Fosfomycin; Fosmidomycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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