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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Centre for Global Health Research, Ghana.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Harry Tagbor, Centre for Global Health Research, Ghana
ClinicalTrials.gov Identifier:
NCT01651416
First received: July 25, 2012
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Malaria
Anaemia
Drug: Artemether-lumefantrine combination
Drug: Dihydroartemisinin Piperaquine combination
Drug: Amodiaquine plus sulphadoxine-pyrimethamine combination
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Centre for Global Health Research, Ghana:

Primary Outcome Measures:
  • Incidence of malaria cases [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Parasitaemia detected by rapid diagnostic test (RDT) and parasitologically confirmation of P. falciparum infection by blood slide..

  • Proportion of children with anaemia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Anaemia is defined as haemoglobin less than <8 g/dL

  • Number of referrals [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Referrals to hospital and admissions due to malaria and other causes

  • Incidence of severe illness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Acceptability of seasonal malaria chemoprevention [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Acceptability of seasonal malaria chemoprevention through Focus Group Discussions and in-depth interviews


Estimated Enrollment: 2400
Study Start Date: July 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Duo-cotecxin

  Eligibility

Ages Eligible for Study:   3 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651416

Contacts
Contact: Harry Tagbor, DrPH +233244417701 ktagbor@yahoo.com
Contact: Gifty D Antwi, MPH +233244596229 giftydufieantwi@yahoo.co.uk

Locations
Ghana
Ejisu-Juaben Municipality Recruiting
Kumasi, Ashanti, Ghana
Contact: Gifty D Antwi, MPH    +233244596229    giftydufieantwi@yahoo.co.uk   
Contact: Ruhama P Mahama, MPH    +233265212568      
Sub-Investigator: Ruhama P Mahama, MPH         
Sponsors and Collaborators
Centre for Global Health Research, Ghana
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Harry Tagbor, DrPH Kwame Nkrumah University of Science and Technology
  More Information

No publications provided

Responsible Party: Harry Tagbor, Principal Investigator, Centre for Global Health Research, Ghana
ClinicalTrials.gov Identifier: NCT01651416     History of Changes
Other Study ID Numbers: QA389
Study First Received: July 25, 2012
Last Updated: July 27, 2012
Health Authority: United Kingdon: Nuffield Centre for International Health and Development, Leeds Institute of Health Sciences
United Kingdon: London School of Hygiene & Tropical Medicine

Keywords provided by Centre for Global Health Research, Ghana:
Home management of malaria
Seasonal malaria chemoprevention

Additional relevant MeSH terms:
Anemia
Malaria
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Piperaquine
Artemether-lumefantrine combination
Lumefantrine
Artemether
Dihydroartemisinin
Fanasil, pyrimethamine drug combination
Sulfadoxine
Amodiaquine
Artemisinins
Pyrimethamine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Folic Acid Antagonists
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 29, 2014