Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated P.Falciparum Malaria in Children

NCT01464138 | Completed Phase 2 DMC

• 1 other identifier: JP012
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label uncontrolled study to determine the efficacy of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated Plasmodium falciparum malaria in children. The primary study endpoints will be the cure rate on Day 28 (PCR corrected). The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.

Conditions

Malaria

Keywords

Malaria

Outcome Measures

Primary Outcomes (1)

• Day 28 cure rate >95%

  28 days

Secondary Outcomes (3)

• Day 7 cure rate of 100%

  Day 6

• Parasite Clearance Time

  0-7 days

• Fever Clearance Time

  0-7 days

Study Arms (1)

Fosmidomycin-Clindamycin

EXPERIMENTAL

Single arm study. Co-administration of Fosmidomycin and Clindamycin.

Drug: Fosmidomycin and Clindamycin co-administration

Interventions

Fosmidomycin and Clindamycin co-administration DRUG

Fosmidomycin sodium syrup at a concentration of 250mg/5ml and clindamycin hydrochloride syrup at a concentration of 75mg/5ml. Administered 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-Clindamycin

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male subjects aged six months to three years
• Female subjects aged six months to three years
• Body weight \>5kg
• 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

You may not qualify if:

• Symptoms/signs of severe malaria, according to WHO criteria
• Body weight \<5kg
• Other plasmodial infections (P vivax, P ovale, P malariae)
• Severe malnutrition with weight for age \<60% 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
• Haemoglobin \<7g/dl
• Adequate anti-malarial treatment within previous 7 days
• Inability to tolerate oral therapy
• Parent or guardian deemed to be unsupportive
• On co-trimoxazole prophylaxis

Sponsors & Collaborators

• Jomaa Pharma GmbH: lead
• Fundacio Clinic Barcelona: collaborator
• Hospital Clinic of Barcelona: collaborator

Study Sites (1)

Centro de Investigacao em Saude da Manhica

Maputo, Mozambique

Location

MeSH Terms

Conditions

Malaria

Interventions

fosmidomycin

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Quique Bassat, PhD

  CRESIB, Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: November 3, 2011
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 3, 2011

Record last verified: 2011-11

Locations

MO (1)