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

NCT01464138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2011-11-03

No results posted yet for this study

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

Interventions

DRUG

Fosmidomycin and Clindamycin co-administration

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)

Sponsors & Collaborators

  • Fundacio Clinic Barcelona

    collaborator OTHER

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Jomaa Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Quique Bassat, PhD · CRESIB, Barcelona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Mozambique

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01464138 on ClinicalTrials.gov