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Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354380
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : October 24, 2006
Sponsor:
Information provided by:
Heidelberg University

Brief Summary:
The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to the safety of an AS-AQ regimen. The secondary objective is to investigate the efficacy of MB-AS and MB-AQ.

Condition or disease Intervention/treatment Phase
Malaria Drug: Methylene blue Drug: Artesunate Drug: Amodiaquine Phase 2

Detailed Description:

Objectives: The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) given over three days in 6-10 year old children with uncomplicated falciparum malaria in a malaria endemic area compared to the safety of a three days AS-AQ regimen. Secondary objectives are to investigate the efficacy of MB-AS and MB-AQ.

Population: Children aged 6-10 years with uncomplicated malaria from Nouna town.

Sample size: N= 180 (n=60 for each group).

Treatment: The participants in the MB-AS group will receive orally twice daily 9mg/kg MB combined with once daily 4mg/kg AS over 3 days. The participants in the MB-AQ group will receive orally twice daily 9mg/kg MB combined with once daily 10mg/kg AQ over 3 days. The participants of the comparator group will receive a 3 day regimen of once daily oral AS (4mg/kg) combined with once daily AQ (10mg/kg).

Endpoints: The primary endpoint is the number of adverse events (AE) after drug intake until day 28. Secondary endpoints are the number of serious adverse events (SAE), adequate clinical and parasitological response (ACPR) rate on day 28, clinical and parasitological failure rates on day 3, 7, 14 and 28, changes in haematocrit until day 28, and fever and parasite clearance time.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria




Primary Outcome Measures :
  1. Incidence of observed and self-reported non-serious adverse events over the 28 days observation period (definition chapter 11)

Secondary Outcome Measures :
  1. Incidence of serious adverse events (definition: chapter 11) over the 28 days observation period
  2. ACPR rate until D28
  3. Early treatment failure (ETF) rate
  4. Late clinical failure (LCF) rate at D14 and D28
  5. Late parasitological failure (LPF) rate at D14 and D28
  6. Fever clearance time
  7. Parasite clearance time
  8. Change in haematocrit after 2, 3, 7, 14 and 28 days compared to baseline


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion criteria:

  • 6-10 year old children
  • Ability to swallow tablets
  • Uncomplicated malaria caused by P. falciparum
  • Asexual parasites ≥ 2000/µl and < 200000/µl
  • Axillary temperature ≥ 37.5°C
  • Burkinabe nationality
  • Informed consent

Exclusion Criteria:

  • Complicated or severe malaria
  • Any apparent significant disease
  • Anaemia (haematocrit < 21%)
  • Treated in the same trial before
  • Antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354380


Locations
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Burkina Faso
Nouna District Hospital
Nouna, Burkina Faso
Sponsors and Collaborators
Heidelberg University
Investigators
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Principal Investigator: Olaf Mueller, MD, MPH Heidelberg University
Principal Investigator: Peter Meissner, MD, MSc Trop Paed Heidelberg University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00354380    
Other Study ID Numbers: SFB544-A8-ASMB2006
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: October 24, 2006
Last Verified: September 2006
Keywords provided by Heidelberg University:
Malaria
Africa
Methalyne-blue
Artesunate
Amodiaquine
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Amodiaquine
Methylene Blue
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action