Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate (JP015)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01002183
Recruitment Status : Withdrawn (Drug combination is no longer pursued)
First Posted : October 27, 2009
Last Update Posted : September 27, 2011
Mahidol University
Thammasat University
Information provided by:
Jomaa Pharma GmbH

October 26, 2009
October 27, 2009
September 27, 2011
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Efficacy of fosmidomycin and clindamycin/artesunate when co-administered to adults with acute uncomplicated P.f. malaria. [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01002183 on Archive Site
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. [ Time Frame: 12 months ]
Same as current
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Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate
Evaluation of Fosmidomycin and Clindamycin When Administered Concurrently to Adult Subjects With Acute Uncomplicated Plasmodium Falciparum Malaria
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
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.
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Fosmidomycin
450 mg capsules, every 12 hrs for 3 days
No Intervention: single arm
Intervention: Drug: Fosmidomycin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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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
Sexes Eligible for Study: All
15 Years to 55 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
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Dr David BA Hutchinson, Jomaa Pharma GmbH
Jomaa Pharma GmbH
  • Mahidol University
  • Thammasat University
Not Provided
Jomaa Pharma GmbH
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP