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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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


Condition Intervention Phase
Malaria
 Drug: Fosmidomycin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Fosmidomycin and Clindamycin When Administered Concurrently to Adult Subjects With Acute Uncomplicated Plasmodium Falciparum Malaria

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Jomaa Pharma GmbH:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Arms Assigned Interventions
No Intervention: single arm
Fos-clin/Arte
 Drug: Fosmidomycin
450 mg capsules, every 12 hrs for 3 days

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

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002183

Locations
Thailand
Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Jomaa Pharma GmbH
Mahidol University
Thammasat University
  More Information

No publications provided

Responsible Party: Dr David BA Hutchinson, Jomaa Pharma GmbH
ClinicalTrials.gov Identifier: NCT01002183     History of Changes
Other Study ID Numbers: JP015
Study First Received: October 26, 2009
Last Updated: September 26, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Jomaa Pharma GmbH:
Malaria
Plasmodium falciparum
acute uncomplicated

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Clindamycin
Clindamycin-2-phosphate
Fosfomycin
 Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013