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OpenTrials
Completed

NCT Number: NCT01157689

Artemether-Lumefantrine Effectiveness in Guinea-Bissau

The routine treatment of children with antimalarials will be monitored. Children with a positive malaria film and/or a positive rapid diagnostic test (RDT) will be included in a follow-up study. The genetic basis of the parasites for developing resistance will be examined. In case of reappearance of parasites the child will be re-treated following the guidelines of the national malaria programme.

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Key information

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bandim Health Project

Bissau, Bissau Codex, 1004, Guinea-Bissau

About this study

Children from the Bandim area in Bissau who are seeking medical advice and who are recommended treatment for malaria in accordance with the current routines will be included as follows:

All children getting the clinical diagnosis of malaria will be registered and basic information collected. Of theses, children fulfilling the inclusion criteria will be included in a follow-up study.

The children included in the follow-up part of the study will be visited on day 7, day 14, day 21, day 28, day 35 and day 42. At each visit the condition of the child will be evaluated, a questionnaire will be filled in and a malaria film and approximately 100 µl blood on filter-paper (for PCR analysis in case of re-parasitaemia) will be taken. Furthermore, on day seven 100 μl blood on filter-paper will be taken for drug-analysis.

Children with parasitaemia detected by only one of the following methods will be excluded from the final analyses of the effectiveness: 1) malaria film, 2) RDT, and 3) PCR.

If the parents do not ensure that the children get the correct medication resulting in a high rate of recrudescence and/or a low drug-concentration on day seven the policy of the National Malaria Programme should be re-evaluated. If the health staff do not follow the guidelines of the National Malaria Programme the reasons why should be elucidated in order to ensure a better adherence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Prescribed an anti-malarial at the Bandim Health Centre
  • Having P. falciparum parasites in a thick film and/or a positive RDT
  • The Bandim address is known (to enable follow up).

Exclusion criteria

  • Children where the parents do not accept to participate in the study.
  • Signs of severe malaria such as convulsion or severe anemia

Treatment and study plan

Primary outcomes

  1. ACPR day 42

    Time frame: day 42

    Malaria slides will be examined weekly during follow-up until day 42. The adequate clinical and parasitological cure rate will to calculated for day 42.

Secondary outcomes

  1. ACPR day 28

    Time frame: 28 days

Other outcomes

  1. Side effects

    Time frame: During follow-up for 42 days

    All possible side effects will be recorded during the 42 day long follow-up.

Sponsors and collaborators

Lead sponsor

Bandim Health Project

Other

Registry information

Official study title

The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum at the Bandim Health Centre

Important dates

Study start
2010
Primary completion
2012
Study completion
2016
First posted
Jul 7, 2010
Registry last updated
May 19, 2021

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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