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This study has been withdrawn prior to enrollment.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

Tracking Information
First Received Date ^ICMJE	October 26, 2009
Last Updated Date	September 26, 2011
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: October 26, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01002183 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 26, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate
Official Title ^ICMJE	Evaluation of Fosmidomycin and Clindamycin When Administered Concurrently to Adult Subjects With Acute Uncomplicated Plasmodium Falciparum Malaria
Brief 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
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Malaria
Intervention ^ICMJE	Drug: Fosmidomycin 450 mg capsules, every 12 hrs for 3 days
Study Arm (s)	No Intervention: single arm Fos-clin/Arte Intervention: Drug: Fosmidomycin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Estimated Enrollment ^ICMJE	40
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	15 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Thailand

Administrative Information
NCT Number ^ICMJE	NCT01002183
Other Study ID Numbers ^ICMJE	JP015
Has Data Monitoring Committee	No
Responsible Party	Dr David BA Hutchinson, Jomaa Pharma GmbH
Study Sponsor ^ICMJE	Jomaa Pharma GmbH
Collaborators ^ICMJE	Mahidol University Thammasat University
Investigators ^ICMJE	Not Provided
Information Provided By	Jomaa Pharma GmbH
Verification Date	August 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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