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CompletedNCT01133314Updated May 26, 2021

Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2

An observational study in Malaria, sponsored by Bandim Health Project. Completed at 1 site in Guinea-Bissau. Open to participants aged Up to 15 Years. Per ClinicalTrials.gov, last updated 2021-05-26.

Sponsored by Bandim Health Project · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
600
Ages
Up to 15 Years
Sex
All
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Study summary

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 have a capillary blood sample taken to verify the diagnosis and to monitor the pattern of resistance.

Read the detailed description

Children from Bissau 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.

All children with a positive malaria film and/or a positive RDT will be asked for a capillary blood sample (app. 50 - 100 microliters on a filterpaper). Using PCR the parasitological diagnosis will be verified and if parasites are identified the resistance patterns will be examined. Both the capillary blood samples and the RDTs (if taken by the health staff) will be used in order to examine whether the RDTs can be used for routine monitoring of resistance in an area.

The study does not interfere in the routine treatment of the health staff. None of the children will be followed.

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Conditions studied

  • Malaria

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03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 600 is close to the median of 600 across 218 observational studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

Bandim Health Project is the lead sponsor of 59 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.

Inclusion criteria

  • Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.

Exclusion criteria

Exclusion Criteria:

  • Children where the parents do not accept to participate in the study.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
600 participants (actual)
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Percentage of children treated for malaria with a parasitological confirmed malaria.

    The blood samples will be analysed for parasites at the end of the study. The results do not have any impact on the treatment of the children.

    Time frame: 6 weeks

Secondary outcomes

  1. Percentage of the parasites with mutations coding for resistance to antimalarials.

    Time frame: 2 years

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Study locations

1 site
  • Bandim Health Project
    Bissau, Bissau Codex, Guinea-Bissau
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01133314
Lead sponsor
Bandim Health Project
Responsible party
Sponsor
First posted
May 28, 2010
Start date
May 2010
Primary completion
Dec 2012
Completion
Jul 2016
Last update
May 26, 2021

Study contacts

Poul-Erik Kofoed, MD, Ph.d.
principal investigator · Bandim Health Project

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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