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

This study has been completed.
Sponsor:
Collaborators:
Fundacio Clinic
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Jomaa Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01464138
First received: October 26, 2009
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Malaria
Drug: Fosmidomycin and Clindamycin co-administration
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children

Resource links provided by NLM:


Further study details as provided by Jomaa Pharma GmbH:

Primary Outcome Measures:
  • Day 28 cure rate >95% [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Day 7 cure rate of 100% [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
  • Parasite Clearance Time [ Time Frame: 0-7 days ] [ Designated as safety issue: No ]
  • Fever Clearance Time [ Time Frame: 0-7 days ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fosmidomycin-Clindamycin
Single arm study. Co-administration of Fosmidomycin and Clindamycin.
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464138

Locations
Mozambique
Centro de Investigacao em Saude da Manhica
Maputo, Mozambique
Sponsors and Collaborators
Jomaa Pharma GmbH
Fundacio Clinic
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Quique Bassat, PhD CRESIB, Barcelona
  More Information

No publications provided

Responsible Party: Jomaa Pharma GmbH
ClinicalTrials.gov Identifier: NCT01464138     History of Changes
Other Study ID Numbers: JP012
Study First Received: October 26, 2009
Last Updated: November 2, 2011
Health Authority: Mozambique: Ministry of Health (MISAU)

Keywords provided by Jomaa Pharma GmbH:
Malaria

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Fosfomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014