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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Zentopharm GmbH.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Albert Schweitzer Hospital
Centro de Investigacao em Saude de Manhica
Information provided by:
Zentopharm GmbH
ClinicalTrials.gov Identifier:
NCT01361269
First received: May 24, 2011
Last updated: May 25, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Malaria
Drug: Fosmidomycin and clindamycin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Zentopharm GmbH:

Primary Outcome Measures:
  • Cure rate [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Cure rate at day 28 will be determined by PCR


Secondary Outcome Measures:
  • cure rate [ Time Frame: day 7 ] [ Designated as safety issue: No ]
    The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.


Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fosmidomycin and clindamycin treatment
All the subject will be given fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg).
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).

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.

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01361269

Contacts
Contact: Saadou Issifou, MD PhD 0024106106256 isaadou2002@yahoo.fr
Contact: Ana Babic, PhD 004970712986020 anababic99@yahoo.fr

Locations
Gabon
Medical Research Unit, Albert Schweitzer Hospital Not yet recruiting
Lambarene, Gabon
Contact: Saadou Issifou    0024106106256    isaadou2002@yahoo.fr   
Sponsors and Collaborators
Zentopharm GmbH
Albert Schweitzer Hospital
Centro de Investigacao em Saude de Manhica
Investigators
Principal Investigator: Saadou Issifou, MD PhD Medical Research Unit, Albert Schweitzer Hospital
  More Information

No publications provided

Responsible Party: Saadou Issifou, Medical Research Unit, Albert Schweitzer Hospital
ClinicalTrials.gov Identifier: NCT01361269     History of Changes
Other Study ID Numbers: FosClinChildren
Study First Received: May 24, 2011
Last Updated: May 25, 2011
Health Authority: Gabon: Ministry of Health

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Clindamycin
Clindamycin-2-phosphate
Fosfomycin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014