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Completed

NCT Number: NCT01651416

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

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Key information

Age range

3 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ejisu-Juaben Municipality

Kumasi, Ashanti Region, Ghana

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artemether-lumefantrine combination

Drug

Dihydroartemisinin Piperaquine combination

Drug

Other names: Duo-cotecxin

Amodiaquine plus sulphadoxine-pyrimethamine combination

Drug

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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..

  2. Proportion of children with anaemia

    Time frame: 12 months

    Anaemia is defined as haemoglobin less than <8 g/dL

  3. Number of referrals

    Time frame: 12 months

    Referrals to hospital and admissions due to malaria and other causes

  4. Incidence of severe illness

    Time frame: 12 months

  5. Incidence of adverse events

    Time frame: 12 months

Other outcomes

  1. Acceptability of seasonal malaria chemoprevention

    Time frame: 2 months

    Acceptability of seasonal malaria chemoprevention through Focus Group Discussions and in-depth interviews

Sponsors and collaborators

Lead sponsor

Centre for Global Health Research, Ghana

Other

Collaborators

  • London School of Hygiene and Tropical Medicine

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jul 27, 2012
Registry last updated
Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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