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Trial record 18 of 232 for:    clindamycin

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

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ClinicalTrials.gov Identifier: NCT01361269
Recruitment Status : Unknown
Verified May 2011 by Zentopharm GmbH.
Recruitment status was:  Not yet recruiting
First Posted : May 26, 2011
Last Update Posted : May 26, 2011
Sponsor:
Collaborators:
Albert Schweitzer Hospital
Centro de Investigacao em Saude de Manhica
Information provided by:
Zentopharm GmbH

Tracking Information
First Submitted Date  ICMJE May 24, 2011
First Posted Date  ICMJE May 26, 2011
Last Update Posted Date May 26, 2011
Study Start Date  ICMJE June 2011
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
Cure rate [ Time Frame: Day 28 ]
Cure rate at day 28 will be determined by PCR
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
cure rate [ Time Frame: day 7 ]
The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria
Official Title  ICMJE Multicentre Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in African Children
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malaria
Intervention  ICMJE 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).
Study Arms  ICMJE 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).
Intervention: Drug: Fosmidomycin and clindamycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 25, 2011)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Gabon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01361269
Other Study ID Numbers  ICMJE FosClinChildren
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Saadou Issifou, Medical Research Unit, Albert Schweitzer Hospital
Study Sponsor  ICMJE Zentopharm GmbH
Collaborators  ICMJE
  • Albert Schweitzer Hospital
  • Centro de Investigacao em Saude de Manhica
Investigators  ICMJE
Principal Investigator: Saadou Issifou, MD PhD Medical Research Unit, Albert Schweitzer Hospital
PRS Account Zentopharm GmbH
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP