Delivery of Malaria Chemoprevention in the Post-discharge Management of Children With Severe Anaemia in Malawi (PMC)

January 30, 2018 updated by: Kamuzu University of Health Sciences

Malaria Chemoprevention With Monthly Treatment With Dihydroartemisinin-Piperaquine for the Post-discharge Management of Severe Anaemia in Children Less Than 5 Years in Malawi

Background and rationale: Children hospitalised with severe anaemia in Africa are at high risk of readmission or death within 6 months after discharge. No strategy specifically addresses this post-discharge period. In Malawi, 3 months of post-discharge malaria chemoprevention (PMC) with monthly 3-day treatment courses of artemether-lumefantrine (AL) in children with severe malarial anaemia prevented 31% of deaths and readmissions. The effect was in addition to the effect of insecticide-treated bednets. There is now need to design and evaluate effective delivery mechanism for PMC within the health system.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objectives: The primary objective of the trial is to determine the optimum PMC delivery mechanism by comparing community- versus health facility-based strategies in order to inform policy.

Study Type: This is a single-centre, matched, cluster randomized, 5-arm, factorial design trial comparing the uptake of PMC-DHP delivered through health facility or community-based approaches with or without SMS/HSA reminders.

Site: 90 villages in the catchment areas of Zomba Central hospital in southern Malawi

Study Population:

Inclusion criteria: convalescent children aged less than 5 years and weighing >5 kg admitted with severe anaemia (haemoglobin<5g/dL / Ht<15%); clinically stable, able to take or switch to oral medication; post-transfusion Hb >5g/dL.

Exclusion criteria: blood loss due to trauma, malignancy, known bleeding disorders or sickle cell trait, known hypersensitivity to study drug, known heart conditions, non-resident in study area, previous participation in study, known need at enrolment for prohibited medication and scheduled surgery during the course of the study. HIV infection and cotrimoxazole prophylaxis are not exclusion criteria

Study Interventions:

All children will receive Dihydroartemisinin-piperaquine (3-day treatment courses, given 2,6 and 10 weeks after discharge) either:

  1. at discharge + SMS Reminder;
  2. at discharge + No SMS Reminder;
  3. at discharge + HSA Reminder;
  4. at OPD + SMS Reminder; or
  5. at OPD + No SMS Reminder

Outcome Measures:

Primary: 100% of PMC drugs uptake (defined as administration of all 3-day treatment courses, given 2, 6 and 10 weeks after discharge) assessed by unannounced spot checks.

Follow-up procedures: Children will be followed up for 15 weeks by passive case detection in 2 phases: Pre-PMC (2 weeks between hospital admission and 2 weeks post-discharge); PMC (2-14 weeks post-discharge)

Sample Size: A sample size of 75 children per arm (375 total children) allows for a detection of 25% increase in uptake from 50% to 75% with 10% loss to follow-up (power 90%, α=0.05).

Data Analysis: The % of children receiving IPTpd according to schedule will be compared by relative risks (95% CI), adjusted for prognostic factors at baseline using log binomial or Poisson regression with adjustment for cluster effects

Study Type

Interventional

Enrollment (Anticipated)

375

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Zomba, Malawi, 0000
        • Recruiting
        • College Of Medicine,Training and Research Unit Of Excellence,Zomba Central Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Haemoglobin <5.0g/dl or PCV <15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital
  2. Age between 4 months (inclusive) and 59 months (inclusive)
  3. Body weight >5kgs

Screening (in-hospital):

  1. Fulfilled the pre-study screening eligibility criteria
  2. Clinically stable, able to switch to oral medication
  3. Subject completed blood transfusion(s) in accordance with routine hospital practice
  4. Able to feed (for breastfed children) or eat (for older children)
  5. Absence of known cardiac problems
  6. Provision of informed consent by parent or guardian

Randomization (at discharge):

  1. Fulfilled screening eligibility criteria
  2. Still clinically stable, able to take oral medication, able to feed (for breastfed children) or eat (for older children) and able to sit unaided (for older children who were able to do so prior to hospitalization

Exclusion Criteria:

  1. Recognised specific other cause of severe anaemia (e.g. trauma, haematological malignancy, known bleeding disorder)
  2. Known sickle cell
  3. Child will reside for more than 25% of the 3.5months study period (i.e. 3 weeks or more) outside of catchment area Enrolment in the study (t=0) at discharge
  4. Previous enrolment in the present study
  5. Known hypersensitivity to study drug
  6. Sickle cell disease
  7. Known need at the time of enrolment for concomitant prohibited medication during the 14 weeks PMC treatment period.
  8. On-going or planned participation into another clinical trial involving on-going or scheduled treatment with medicinal products during the course of the study (3.5 months from enrolment)
  9. Known need, or scheduled surgery during the course of the study (3.5 months)
  10. Suspected non-compliance with the follow-up schedule
  11. Known heart conditions, or family history of congenital prolongation of the QTc interval

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Drug + short message(SMS) reminder
dihydroartemesinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with SMS reminders prior to each treatment course
Drug: dihydroartemisinin-piperaquine
Other: short message(SMS) reminder
Other: Drug + no short message(SMS) reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) without SMS reminders prior to each treatment course.
Drug: dihydroartemisinin-piperaquine
Other: Drug+ Health worker reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with Health surveillance assistants reminders prior to each treatment course.
Drug: dihydroartemisinin-piperaquine
Other: Health worker reminder
Health surveillance assistants reminders prior to each treatment course
Other: Drug at hospital + SMS reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) collected at the outpatient department without an SMS reminders prior to each treatment course.
Drug: dihydroartemisinin-piperaquine
Other: Drug at Hospital+no SMS reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) collected at the outpatient department with a short message reminder prior to each treatment course
Drug: dihydroartemisinin-piperaquine
Other: message(SMS) reminder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of those with 100 % uptake of PMC drugs during the 15 weeks of the study period.
Time Frame: 15 weeks
100 % uptake is defined as administration of all study drugs and compliance to study visits during the course of 15 weeks.
15 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of those with 60% uptake of PMC drugs during the 15 weeks of the study period.
Time Frame: 15 weeks
60 % uptake is defined as administration of 6 or more [but less than 9] of the daily dosages out of the total of 9 during the 15 week study period.
15 weeks
Proportion of those with 30 % uptake of PMC drugs during the 15 week trial period.
Time Frame: 15 weeks
30 % PMC uptake is defined as administration of 3 or more [but less than 6] of the daily dosages out of the total of 9 during the 15 week trial period.
15 weeks
Proportion of those with <30% uptake of PMC drugs during the 15 week trial period.
Time Frame: 15 weeks
<30 % PMC uptake is defined as administration of less than 3 of the daily dosages out of the total of 9 assessed during the 15 week trial period.
15 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-causes of deaths and all-causes of hospital re-admissions during the 15 week trial period.
Time Frame: 15 weeks
Assessment of all children who die or are hospitalised during the trial period
15 weeks
Assessment of the added costs of the interventions to the health system and the individual patients by conducting interviews during the 15 week trial period.
Time Frame: 15 weeks
15 weeks
Assessment of how the study interventions are acceptable by patients and health workers by conducting focus group discussions and using self administered questionnaires during the 15 week trial period.
Time Frame: 15 weeks
15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kamuzu University of Health Sciences

Collaborators

London School of Hygiene and Tropical Medicine
University of Bergen
The Research Council of Norway
Imperial College London
University of Minnesota
University of Amsterdam
Makerere University
Liverpool School of Tropical Medicine
Kenya Medical Research Institute
Ministry of Health, Malawi
Ministry of Health and Population, Malawi

Investigators

  • Principal Investigator: Kamija Phiri, PhD, University of Malawi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2016

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

February 13, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (Estimate)

March 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.02/15/1679

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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