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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01651416
Other study ID # QA389
Secondary ID
Status Completed
Phase Phase 4
First received July 25, 2012
Last updated September 17, 2015
Start date July 2012
Est. completion date July 2013

Study information

Verified date September 2015
Source Centre for Global Health Research, Ghana
Contact n/a
Is FDA regulated No
Health authority United Kingdon: Nuffield Centre for International Health and Development, Leeds Institute of Health SciencesUnited Kingdon: London School of Hygiene & Tropical Medicine
Study type Interventional

Clinical Trial Summary

In areas of Africa where malaria is only a problem during a short rainy season, monthly courses of antimalarial drugs can provide very effective prevention of malaria in children. This approach, called intermittent preventive treatment in children (IPTc) but now known as Seasonal Malaria Chemoprevention (SMC), may also be useful in large areas of Africa where malaria is transmitted for longer each year. It is uncertain if IPTc would be effective, acceptable to communities or sustainable when delivered over a longer period, but this is an important public health question of key interest to policy makers, because in areas with a longer transmission season, the burden of malaria is typically higher than in highly seasonal areas.

Another form of prevention that would be operationally easier for African countries to put into practice would be to treat malaria patients with long-lasting antimalarials, which protect children against further malaria episodes for several weeks. Because malaria disproportionately affects certain high risk children more than others, causing repeated attacks of fever and leading to severe anaemia, long-acting drugs may be a simple and effective way to target limited resources at the individuals who most need protection. This may be particularly beneficial where malaria is a seasonal problem, because repeated malaria attacks will not only be borne by a few unfortunate children, but will also occur close together in time.

The investigators propose a clinical trial to evaluate these two forms of chemoprevention in Kumasi, Ghana, an area with an extended malaria transmission season. Children under 5 years of age currently have access to diagnosis and treatment of malaria via by community based health workers. Children enrolled in the study will receive either the standard community-based diagnosis and treatment, treatment with a longer-acting artemisinin combination therapy (ACT), or standard care plus five monthly courses of seasonal malaria chemoprevention (SMC) during the peak in transmission.


Recruitment information / eligibility

Status Completed
Enrollment 2400
Est. completion date July 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 59 Months
Eligibility Inclusion Criteria:

- Children aged between 3-59 months

- Care giver or parent willing to participate and have given informed consent

- Children living in the study area

Exclusion Criteria:

- Children who are unable to take and retain medication

- Children who have a severe or chronic illness

- Children who have a history of serious adverse reaction to the study drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Artemether-lumefantrine combination

Dihydroartemisinin Piperaquine combination

Amodiaquine plus sulphadoxine-pyrimethamine combination


Locations

Country Name City State
Ghana Ejisu-Juaben Municipality Kumasi Ashanti

Sponsors (2)

Lead Sponsor Collaborator
Centre for Global Health Research, Ghana London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Ghana, 

Outcome

Type Measure Description Time frame Safety issue
Other Acceptability of seasonal malaria chemoprevention Acceptability of seasonal malaria chemoprevention through Focus Group Discussions and in-depth interviews 2 months No
Primary Incidence of malaria cases Incidence of malaria cases recorded by the community health workers (CHWs) and at the study health centres. Malaria will be defined as fever or history of fever combined with parasitologically confirmed P. falciparum infection by blood slide. Management of suspected malaria cases reporting to CHWs and health centres will be according to rapid diagnostic test (RDT). 12 months No
Secondary Proportion of children with parasitaemia Parasitaemia detected by rapid diagnostic test (RDT) and parasitologically confirmation of P. falciparum infection by blood slide.. 12 months No
Secondary Proportion of children with anaemia Anaemia is defined as haemoglobin less than <8 g/dL 12 months No
Secondary Number of referrals Referrals to hospital and admissions due to malaria and other causes 12 months No
Secondary Incidence of severe illness 12 months No
Secondary Incidence of adverse events 12 months Yes
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