Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate (JP015)

This study has been withdrawn prior to enrollment.
(Drug combination is no longer pursued)
Sponsor:
Collaborators:
Mahidol University
Thammasat University
Information provided by:
Jomaa Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01002183
First received: October 26, 2009
Last updated: September 26, 2011
Last verified: August 2010

October 26, 2009
September 26, 2011
Not Provided
Not Provided
Efficacy of fosmidomycin and clindamycin/artesunate when co-administered to adults with acute uncomplicated P.f. malaria. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01002183 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malaria
Drug: Fosmidomycin
450 mg capsules, every 12 hrs for 3 days
No Intervention: single arm
Fos-clin/Arte
Intervention: Drug: Fosmidomycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
40
Not Provided
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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
Both
15 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01002183
JP015
No
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