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

Primary Purpose

Malaria, Anaemia

Status
Completed
Phase
Phase 4
Locations
Ghana
Study Type
Interventional
Intervention
Artemether-lumefantrine combination
Dihydroartemisinin Piperaquine combination
Amodiaquine plus sulphadoxine-pyrimethamine combination
Sponsored by
Centre for Global Health Research, Ghana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring Home management of malaria, Seasonal malaria chemoprevention

Eligibility Criteria

3 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ejisu-Juaben Municipality

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

HMM using short-acting ACT

HMM using short-acting ACT plus SMC

HMM using a long-acting ACT

Arm Description

Home management of malaria using Artemether-lumefantrine combination (a short-acting ACT) for treatment in children with malaria diagnosed using RDTs

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.

Home management of malaria using Dihydroartemisinin Piperaquine combination (a long-acting ACT) for treatment in children with malaria diagnosed using RDTs

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2012
Last Updated
September 17, 2015
Sponsor
Centre for Global Health Research, Ghana
Collaborators
London School of Hygiene and Tropical Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01651416
Brief Title
Seasonal Malaria Chemoprevention Versus Home Management of Malaria in Children Under 5 Years in Ghana
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Global Health Research, Ghana
Collaborators
London School of Hygiene and Tropical Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Anaemia
Keywords
Home management of malaria, Seasonal malaria chemoprevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HMM using short-acting ACT
Arm Type
Active Comparator
Arm Description
Home management of malaria using Artemether-lumefantrine combination (a short-acting ACT) for treatment in children with malaria diagnosed using RDTs
Arm Title
HMM using short-acting ACT plus SMC
Arm Type
Experimental
Arm Description
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.
Arm Title
HMM using a long-acting ACT
Arm Type
Experimental
Arm Description
Home management of malaria using Dihydroartemisinin Piperaquine combination (a long-acting ACT) for treatment in children with malaria diagnosed using RDTs
Intervention Type
Drug
Intervention Name(s)
Artemether-lumefantrine combination
Intervention Type
Drug
Intervention Name(s)
Dihydroartemisinin Piperaquine combination
Other Intervention Name(s)
Duo-cotecxin
Intervention Type
Drug
Intervention Name(s)
Amodiaquine plus sulphadoxine-pyrimethamine combination
Primary Outcome Measure Information:
Title
Incidence of malaria cases
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Proportion of children with parasitaemia
Description
Parasitaemia detected by rapid diagnostic test (RDT) and parasitologically confirmation of P. falciparum infection by blood slide..
Time Frame
12 months
Title
Proportion of children with anaemia
Description
Anaemia is defined as haemoglobin less than <8 g/dL
Time Frame
12 months
Title
Number of referrals
Description
Referrals to hospital and admissions due to malaria and other causes
Time Frame
12 months
Title
Incidence of severe illness
Time Frame
12 months
Title
Incidence of adverse events
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Acceptability of seasonal malaria chemoprevention
Description
Acceptability of seasonal malaria chemoprevention through Focus Group Discussions and in-depth interviews
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Tagbor, DrPH
Organizational Affiliation
Kwame Nkrumah University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ejisu-Juaben Municipality
City
Kumasi
State/Province
Ashanti
Country
Ghana

12. IPD Sharing Statement

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

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