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Fosmidomycin and Azithromycin for Acute Uncomplicated Plasmodium Falciparum Malaria (P. Malaria) in Adults

NCT ID: NCT01464125

Last Updated: 2011-11-03

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-12-31

Brief Summary

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The aim of this study is to evaluate the role of azithromycin as a possible combination partner 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.

The dose of fosmidomycin, equivalent to 30mg/kg twice daily for three days, selected for evaluation in this proof of concept study is derived from the highest dose that was administered in the Phase I safety tolerance studies. While the recommended dose of azithromycin for the treatment of bacterial infections is 250mg daily for three days, higher doses of up to 1500mg daily for three days have been evaluated for the treatment of malaria, in combination with artesunate or quinine.

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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Fos-Azi

Open label single arm concurrent administration of fosmidomycin and azithromycin.

Group Type EXPERIMENTAL

Fosmidomycin

Intervention Type DRUG

Fosmidomycin sodium capsules 450 mg x 4 twelve-hourly for three days

Azithromycin

Intervention Type DRUG

Azithromycin capsules 250 mg x 3 twelve-hourly for three days

Interventions

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Fosmidomycin

Fosmidomycin sodium capsules 450 mg x 4 twelve-hourly for three days

Intervention Type DRUG

Azithromycin

Azithromycin capsules 250 mg x 3 twelve-hourly for three 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 ≤ 18.5 kg/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 \> 125 umol/L or 3 mg/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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Responsibility Role SPONSOR

Principal Investigators

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Srivicha Krudsood, Prof

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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JP011

Identifier Type: -

Identifier Source: org_study_id