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Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria

Primary Purpose

Malaria

Status
Unknown status
Phase
Phase 2
Locations
Gabon
Study Type
Interventional
Intervention
Fosmidomycin and clindamycin
Sponsored by
Zentopharm GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects aged three to ten years
  • Body weight ≥12kg
  • Acute (symptoms lasting less than 14 days) uncomplicated P falciparum malaria
  • Asexual parasitaemia between 1,000/µL and 200,000/µL
  • Ability to tolerate oral therapy
  • Willingness of the parent or guardian to provide informed signed consent

Exclusion Criteria:

  • Symptoms/signs of severe malaria, according to WHO criteria (see appendix I)
  • Body weight <12kg
  • Other concomitant plasmodial infections (P vivax, P ovale, P malariae)
  • Severe malnutrition with weight for height <70% (according to WHO tables) or clinical kwashiorkor
  • Gastro-intestinal disturbance with persistent vomiting (> three episodes within previous 24 hours) and/or diarrhoea (> 5 loose stools in the preceding 24 hours)
  • Concomitant disease masking assessment of response including sickle cell disease and severe cardiac, hepatic or renal impairment
  • Packed cell volume (PCV) on arrival <22%
  • Adequate anti-malarial treatment within previous 7 days
  • Inability to tolerate oral therapy
  • Parent or guardian deemed to be unsupportive
  • On co-trimoxazole prophylaxis
  • Any known allergies to the investigational products

Sites / Locations

  • Medical Research Unit, Albert Schweitzer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fosmidomycin and clindamycin treatment

Arm Description

All the subject will be given fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg).

Outcomes

Primary Outcome Measures

Cure rate
Cure rate at day 28 will be determined by PCR

Secondary Outcome Measures

cure rate
The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.

Full Information

First Posted
May 24, 2011
Last Updated
May 25, 2011
Sponsor
Zentopharm GmbH
Collaborators
Albert Schweitzer Hospital, Centro de Investigacao em Saude de Manhica
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1. Study Identification

Unique Protocol Identification Number
NCT01361269
Brief Title
Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria
Official Title
Multicentre Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in African Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zentopharm GmbH
Collaborators
Albert Schweitzer Hospital, Centro de Investigacao em Saude de Manhica

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The investigators will test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment in acute uncomplicated malaria in children aged 3-10 years.
Detailed Description
Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The goal of this study is to assess a new drug combination, fosmidomycin-clindamycin. The primary objective of the study is to assess and compare the efficacy, safety and tolerance (between sites) of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated Plasmodium falciparum malaria in children in Mozambique and Gabon. The secondary objective is to differentiate between recrudescent parasitaemia and reinfection in the event of recurrent parasitaemia developing within the 28-day follow-up period, to determine the population pharmacokinetics of fosmidomycin when co-administered orally with clindamycin and to compare the in vitro sensitivity of isolates of Plasmodium falciparum to fosmidomycin. The trial will include 100 children aged 3-10 years, divided between clinical sites of Gabon and Mozambique.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fosmidomycin and clindamycin treatment
Arm Type
Experimental
Arm Description
All the subject will be given fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg).
Intervention Type
Drug
Intervention Name(s)
Fosmidomycin and clindamycin
Intervention Description
The study drugs will be co-administered under supervision by a study physician or nurse in doses of fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg).
Primary Outcome Measure Information:
Title
Cure rate
Description
Cure rate at day 28 will be determined by PCR
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
cure rate
Description
The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.
Time Frame
day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects aged three to ten years Body weight ≥12kg Acute (symptoms lasting less than 14 days) uncomplicated P falciparum malaria Asexual parasitaemia between 1,000/µL and 200,000/µL Ability to tolerate oral therapy Willingness of the parent or guardian to provide informed signed consent Exclusion Criteria: Symptoms/signs of severe malaria, according to WHO criteria (see appendix I) Body weight <12kg Other concomitant plasmodial infections (P vivax, P ovale, P malariae) Severe malnutrition with weight for height <70% (according to WHO tables) or clinical kwashiorkor Gastro-intestinal disturbance with persistent vomiting (> three episodes within previous 24 hours) and/or diarrhoea (> 5 loose stools in the preceding 24 hours) Concomitant disease masking assessment of response including sickle cell disease and severe cardiac, hepatic or renal impairment Packed cell volume (PCV) on arrival <22% Adequate anti-malarial treatment within previous 7 days Inability to tolerate oral therapy Parent or guardian deemed to be unsupportive On co-trimoxazole prophylaxis Any known allergies to the investigational products
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saadou Issifou, MD PhD
Phone
0024106106256
Email
isaadou2002@yahoo.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Babic, PhD
Phone
004970712986020
Email
anababic99@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saadou Issifou, MD PhD
Organizational Affiliation
Medical Research Unit, Albert Schweitzer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Research Unit, Albert Schweitzer Hospital
City
Lambarene
Country
Gabon
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saadou Issifou
Phone
0024106106256
Email
isaadou2002@yahoo.fr

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria

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