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Completed

NCT Number: NCT00545935

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

The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre de Recherche en Sante de Nouna

Nouna, Burkina Faso

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 0.5-5 year (6-59 months) old children
  • uncomplicated malaria caused by P. falciparum
  • asexual parasites ≥ 2000/µ and ≤ 200000/µ
  • axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours
  • Burkinabe nationality
  • informed consent

Exclusion criteria

  • complicated or severe malaria
  • any apparent significant disease
  • anaemia (haematocrit < 21%)
  • treated in the same trial before
  • modern antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine

Treatment and study plan

Methylenblue-Amodiaquine (MB-AQ)

Drug

For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ

Methylenblue-Artesunate (MB-AS)

Drug

3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days

artesunate-amodiaquine (AS-AQ)

Drug

For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.

Primary outcomes

  1. Incidence of observed and self-reported non-serious adverse events over the 28 days observation period

    Time frame: 28 days

Secondary outcomes

  1. Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)

    Time frame: 28 days

  2. Early treatment failure (ETF) rate

    Time frame: 28 days

  3. Late clinical failure (LCF) rate at D14 and D28

    Time frame: 28 days

  4. Late parasitological failure (LPF) rate at D14 and D28

    Time frame: 28 days

  5. Fever clearance time

    Time frame: 28 days

  6. Parasite clearance time

    Time frame: 28 days

  7. Change in haematocrit after 2,14 and 28 days compared to baseline

    Time frame: 28 days

  8. MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso: RCT in the Frame of the A8 Project of SFB 544

Important dates

Study start
2007
Study completion
2007
First posted
Oct 17, 2007
Registry last updated
Feb 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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