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

Condition(s) targeted: Malaria

Intervention: Fosmidomycin and clindamycin (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Zentopharm GmbH

Official(s) and/or principal investigator(s):
Saadou Issifou, MD PhD, Principal Investigator, Affiliation: Medical Research Unit, Albert Schweitzer Hospital

Overall contact:
Saadou Issifou, MD PhD, Phone: 0024106106256, Email: isaadou2002@yahoo.fr

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.

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Cure rate

Secondary outcome: cure rate

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.

Minimum age: 3 Years. Maximum age: 10 Years. Gender(s): Both.

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

Saadou Issifou, MD PhD, Phone: 0024106106256, Email: isaadou2002@yahoo.fr

Medical Research Unit, Albert Schweitzer Hospital, Lambarene, Gabon; Not yet recruiting
Saadou Issifou, Phone: 0024106106256, Email: isaadou2002@yahoo.fr

Starting date: June 2011
Last updated: May 25, 2011