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
  Purpose

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.


Condition
Malaria

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum at the Bandim Health Centre

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • ACPR day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 500
Study Start Date: March 2010
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coartem, chloroquine, quinine
All children with a positive malaria test will included. Results will be subanalysed acording to treatment given by routine health staff.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157689

Locations
Guinea-Bissau
Bandim Health Project
Bissau, Bissau Codex, Guinea-Bissau, 1004
Sponsors and Collaborators
Bandim Health Project
  More Information

No publications provided

Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT01157689     History of Changes
Other Study ID Numbers: AL-eff 2010
Study First Received: July 6, 2010
Last Updated: March 16, 2013
Health Authority: Ministry of Health,Guinea-Bissau:

Keywords provided by Bandim Health Project:
malaria
children
Guinea-Bissau
artemether
lumefantrine
effectiveness

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artemether
Lumefantrine
Artemether-lumefantrine combination
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on August 28, 2014