Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate
Information source: Jomaa Pharma GmbH
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: Fosmidomycin (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Jomaa Pharma GmbH Overall contact:
David BA Hutchinson, MD, Phone: +49 40 6117 15, Email: david.hutchinson@jomaa-pharma.com
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
Clinical Details
Official title: Evaluation of Fosmidomycin and Clindamycin When Administered Concurrently to Adult Subjects With Acute Uncomplicated Plasmodium Falciparum Malaria
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Efficacy of fosmidomycin and clindamycin/artesunate when co-administered to adults with acute uncomplicated P.f. malaria.
Secondary outcome: To determine the viability and infectivity of gametocytes induced by the co-administration of fosmidomycin with clindamycin or with clindamycin plus artesunate to adult subjects with acute uncomplicated Plasmodium falciparum malaria.
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 and ubiquinones. This is effected through blockade of the
non-mevalonate pathway by fosmidomycin as a potent inhibitor of 1-deoxy-D-xylulose
5-phosphate reductoisomerase coupled with targeting of protein biosynthesis by azithromycin
through binding to the 50S ribosomal subunit. This mode of action contrasts with the ability
of the human host to utilise the mevalonate pathway for isoprenoid synthesis and accounts
for the safety profiles of both drugs through the mechanism of selective toxicity. Moreover
it affords protection against cross resistance with existing chemotherapeutic agents.
Eligibility
Minimum age: 15 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
David BA Hutchinson, MD, Phone: +49 40 6117 15, Email: david.hutchinson@jomaa-pharma.com
Mahidol University, Bangkok 10400, Thailand
Additional Information
Starting date: September 2010
Last updated: August 11, 2010
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