Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 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: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; 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 ≤ 18.5kg/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