Trial | NCT01361269  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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.
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.
Study Started
Jun 30
2011
Primary Completion
Sep 30
2011
Anticipated
Study Completion
Dec 31
2011
Anticipated
Last Update
May 26
2011
Estimate

Drug Fosmidomycin and clindamycin

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).

Fosmidomycin and clindamycin treatment Experimental

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).

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
No Results Posted