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

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.

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.

Study Overview

• Status: Completed
• Conditions: Malaria; Anaemia
• Intervention / Treatment: Drug: Artemether-lumefantrine combination; Drug: Amodiaquine plus sulphadoxine-pyrimethamine combination; Drug: Dihydroartemisinin Piperaquine combination

• Study Type: Interventional
• Enrollment (Actual): 2400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Ghana
  • Ashanti
    • Kumasi, Ashanti, Ghana
      • Ejisu-Juaben Municipality

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HMM using short-acting ACT; Home management of malaria using Artemether-lumefantrine combination (a short-acting ACT) for treatment in children with malaria diagnosed using RDTs	Drug: Artemether-lumefantrine combination
Experimental: HMM using short-acting ACT plus SMC; Home management of malaria using using Artemether-lumefantrine combination (a short-acting ACT) for treatment in children with malaria diagnosed using RDTs plus seasonal malaria chemoprevention with Amodiaquine plus sulphadoxine-pyrimethamine combination.	Drug: Artemether-lumefantrine combination; Drug: Amodiaquine plus sulphadoxine-pyrimethamine combination
Experimental: HMM using a long-acting ACT; Home management of malaria using Dihydroartemisinin Piperaquine combination (a long-acting ACT) for treatment in children with malaria diagnosed using RDTs	Drug: Dihydroartemisinin Piperaquine combination; Other Names: Duo-cotecxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of children with parasitaemia	Parasitaemia detected by rapid diagnostic test (RDT) and parasitologically confirmation of P. falciparum infection by blood slide..	12 months
Proportion of children with anaemia	Anaemia is defined as haemoglobin less than <8 g/dL	12 months
Number of referrals	Referrals to hospital and admissions due to malaria and other causes	12 months
Incidence of severe illness		12 months
Incidence of adverse events		12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of seasonal malaria chemoprevention	Acceptability of seasonal malaria chemoprevention through Focus Group Discussions and in-depth interviews	2 months

Collaborators and Investigators

• Sponsor: Centre for Global Health Research, Ghana
• Collaborators: London School of Hygiene and Tropical Medicine
• Investigators: Principal Investigator: Harry Tagbor, DrPH, Kwame Nkrumah University of Science and Technology

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 25, 2012
• First Submitted That Met QC Criteria: July 26, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Estimate): September 18, 2015
• Last Update Submitted That Met QC Criteria: September 17, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Seasonal malaria chemoprevention; Home management of malaria
• Additional Relevant MeSH Terms: Infections; Hematologic Diseases; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria; Anemia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Anti-Infective Agents, Urinary; Renal Agents; Lumefantrine; Artemether; Pyrimethamine; Artemether, Lumefantrine Drug Combination; Piperaquine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Amodiaquine; Artenimol
• Other Study ID Numbers: QA389