Clinical trial NCT01361269: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malaria
Lead sponsor: Zentopharm GmbH
Sponsor class: INDUSTRY
Collaborators: name: Albert Schweitzer Hospital
name: Centro de Investigacao em Saude de Manhica
First posted: 2011-05-26
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cure rate
timeFrame: Day 28
Secondary outcomes:
measure: cure rate
timeFrame: day 7
Other outcomes:
Locations:
city: Lambarene
country: Gabon
facility: Medical Research Unit, Albert Schweitzer Hospital
Study officials:
affiliation: Medical Research Unit, Albert Schweitzer Hospital
name: Saadou Issifou, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: