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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01361269
• Other study ID #: FosClinChildren
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 24, 2011
• Last updated: May 25, 2011
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: May 2011
• Source: Zentopharm GmbH
• Contact: Saadou Issifou, MD PhD
• Phone: 0024106106256
• Email: isaadou2002[@]yahoo.fr
• Is FDA regulated: No
• Health authority: Gabon: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

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).

Locations

Country	Name	City	State
Gabon	Medical Research Unit, Albert Schweitzer Hospital	Lambarene

Sponsors (3)

Lead Sponsor	Collaborator
Zentopharm GmbH	Albert Schweitzer Hospital, Centro de Investigacao em Saude de Manhica

Country where clinical trial is conducted

Gabon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate	Cure rate at day 28 will be determined by PCR	Day 28	No
Secondary	cure rate	The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.	day 7	No