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

NCT01651416 | Completed Phase 4 DMC

• 1 other identifier: QA389
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malaria; Anaemia

Keywords

Home management of malaria; Seasonal malaria chemoprevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Proportion of children with parasitaemia

  12 months

• Proportion of children with anaemia

  12 months

• Number of referrals

  12 months

• Incidence of severe illness

  12 months

• Incidence of adverse events

  12 months

Other Outcomes (1)

• Acceptability of seasonal malaria chemoprevention

  2 months

Study Arms (3)

HMM using short-acting ACT

ACTIVE COMPARATOR

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

HMM using short-acting ACT plus SMC

EXPERIMENTAL

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

HMM using a long-acting ACT

EXPERIMENTAL

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

Interventions

Artemether-lumefantrine combination DRUG

HMM using short-acting ACT; HMM using short-acting ACT plus SMC

Dihydroartemisinin Piperaquine combination DRUG

Also known as: Duo-cotecxin

HMM using a long-acting ACT

Amodiaquine plus sulphadoxine-pyrimethamine combination DRUG

HMM using short-acting ACT plus SMC

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 3-59 months
• Care giver or parent willing to participate and have given informed consent
• Children living in the study area

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Global Health Research, Ghana: lead
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Ejisu-Juaben Municipality

Kumasi, Ashanti Region, Ghana

Location

MeSH Terms

Conditions

Malaria; Anemia

Interventions

Artemether, Lumefantrine Drug Combination; Amodiaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Harry Tagbor, DrPH

  Kwame Nkrumah University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 27, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

GH (1)