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Artemether-Lumefantrine Effectiveness in Guinea-Bissau

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT01157689
First received: July 6, 2010
Last updated: March 16, 2013
Last verified: March 2013

July 6, 2010
March 16, 2013
March 2010
December 2012   (final data collection date for primary outcome measure)
ACPR day 42 [ Time Frame: day 42 ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT01157689 on ClinicalTrials.gov Archive Site
ACPR day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Not Provided
Side effects [ Time Frame: During follow-up for 42 days ] [ Designated as safety issue: Yes ]
All possible side effects will be recorded during the 42 day long follow-up.
Not Provided
 
Artemether-Lumefantrine Effectiveness in Guinea-Bissau
The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum at the Bandim Health Centre

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Capillary blood samples for drug concentration analysis and for PCR for identifying the malaria parasites

Non-Probability Sample

Children diagnosed as having malaria at Bandim Health Center in Bissau. Of these all children with a positive malaria film and/or a positive rapid diagnostic test will be included in an observational follow-up study.

Malaria
Not Provided
Coartem, chloroquine, quinine
All children with a positive malaria test will included. Results will be subanalysed acording to treatment given by routine health staff.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
June 2014
December 2012   (final data collection date for primary outcome measure)

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
Both
up to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Guinea-Bissau
 
NCT01157689
AL-eff 2010
No
Bandim Health Project
Bandim Health Project
Not Provided
Not Provided
Bandim Health Project
March 2013

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