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Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate

NCT ID: NCT01002183

Last Updated: 2011-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Malaria

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single arm

Fos-clin/Arte

Group Type NO_INTERVENTION

Fosmidomycin

Intervention Type DRUG

450 mg capsules, every 12 hrs for 3 days

Interventions

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Fosmidomycin

450 mg capsules, every 12 hrs for 3 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role collaborator

Thammasat University

OTHER

Sponsor Role collaborator

Jomaa Pharma GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Jomaa Pharma GmbH

Locations

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Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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JP015

Identifier Type: -

Identifier Source: org_study_id