Seasonal Malaria Chemoprevention Versus Home Management of Malaria in Children Under 5 Years in Ghana

Malaria Clinical Trial

Official title:

An Individually Randomised Trial of Seasonal Malaria Chemoprevention Versus a Long-acting Artemisinin Combination Therapy for the Prevention of Malaria and Anaemia in Children Living in an Area of Extended Seasonal Transmission in Ghana.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651416
• Other study ID #: QA389
• 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

• Anaemia
• Malaria

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