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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01651416
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : September 18, 2015
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Harry Tagbor, Centre for Global Health Research, Ghana

Tracking Information
First Submitted Date  ICMJE July 25, 2012
First Posted Date  ICMJE July 27, 2012
Last Update Posted Date September 18, 2015
Study Start Date  ICMJE July 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2012)
Incidence of malaria cases [ Time Frame: 12 months ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2012)
  • Proportion of children with parasitaemia [ Time Frame: 12 months ]
    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 ]
    Anaemia is defined as haemoglobin less than <8 g/dL
  • Number of referrals [ Time Frame: 12 months ]
    Referrals to hospital and admissions due to malaria and other causes
  • Incidence of severe illness [ Time Frame: 12 months ]
  • Incidence of adverse events [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 26, 2012)
Acceptability of seasonal malaria chemoprevention [ Time Frame: 2 months ]
Acceptability of seasonal malaria chemoprevention through Focus Group Discussions and in-depth interviews
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Seasonal Malaria Chemoprevention Versus Home Management of Malaria in Children Under 5 Years in Ghana
Official Title  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Malaria
  • Anaemia
Intervention  ICMJE
  • Drug: Artemether-lumefantrine combination
  • Drug: Dihydroartemisinin Piperaquine combination
    Other Name: Duo-cotecxin
  • Drug: Amodiaquine plus sulphadoxine-pyrimethamine combination
Study Arms  ICMJE
  • 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
    Intervention: 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.
    Interventions:
    • 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
    Intervention: Drug: Dihydroartemisinin Piperaquine combination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2012)
2400
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ghana
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01651416
Other Study ID Numbers  ICMJE QA389
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Harry Tagbor, Centre for Global Health Research, Ghana
Study Sponsor  ICMJE Centre for Global Health Research, Ghana
Collaborators  ICMJE London School of Hygiene and Tropical Medicine
Investigators  ICMJE
Principal Investigator: Harry Tagbor, DrPH Kwame Nkrumah University of Science and Technology
PRS Account Centre for Global Health Research, Ghana
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP