Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2

The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Bissau - 2

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01133314

Enrollment

600

Registered

2010-05-28

Start date

2010-05-31

Completion date

2016-07-31

Last updated

2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Brief 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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 15 Years

Healthy volunteers

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

* Children where the parents do not accept to participate in the study.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of children treated for malaria with a parasitological confirmed malaria.	6 weeks	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.

Secondary

Measure	Time frame
Percentage of the parasites with mutations coding for resistance to antimalarials.	2 years

Countries

Guinea-Bissau

Outcome results