Back to results

Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate (JP015)

Primary Purpose

Malaria

Status

Withdrawn

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Fosmidomycin

About this trial

This is an interventional treatment trial for Malaria focused on measuring Malaria, Plasmodium falciparum, acute uncomplicated

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mahidol University

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

single arm

Arm Description

Fos-clin/Arte

Outcomes

Primary Outcome Measures

Efficacy of fosmidomycin and clindamycin/artesunate when co-administered to adults with acute uncomplicated P.f. malaria.

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.

Full Information

NCT ID

NCT01002183

First Posted

October 26, 2009

Last Updated

September 26, 2011

Sponsor

Jomaa Pharma GmbH

Collaborators

Mahidol University, Thammasat University

1. Study Identification

Unique Protocol Identification Number

NCT01002183

Brief Title

Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate

Acronym

JP015

Official Title

Evaluation of Fosmidomycin and Clindamycin When Administered Concurrently to Adult Subjects With Acute Uncomplicated Plasmodium Falciparum Malaria

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Withdrawn

Why Stopped

Drug combination is no longer pursued

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Jomaa Pharma GmbH

Collaborators

Mahidol University, Thammasat University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

Malaria, Plasmodium falciparum, acute uncomplicated

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

single arm

Arm Type

No Intervention

Arm Description

Fos-clin/Arte

Intervention Type

Drug

Intervention Name(s)

Fosmidomycin

Intervention Description

450 mg capsules, every 12 hrs for 3 days

Primary Outcome Measure Information:

Title

Efficacy of fosmidomycin and clindamycin/artesunate when co-administered to adults with acute uncomplicated P.f. malaria.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Mahidol University

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate

We'll reach out to this number within 24 hrs