Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02721420
Recruitment Status : Unknown
Verified January 2018 by University of Malawi College of Medicine.
Recruitment status was:  Recruiting
First Posted : March 29, 2016
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
University of Bergen
The Research Council of Norway
Makerere University
Liverpool School of Tropical Medicine
Kenya Medical Research Institute
University of Amsterdam
Imperial College London
London School of Hygiene and Tropical Medicine
University of Minnesota
Ministry of Health and Population, Malawi
Ministry of Health, Malawi
Information provided by (Responsible Party):
University of Malawi College of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malaria Severe Anemia Drug: dihydroartemisinin-piperaquine Other: message(SMS) reminder Other: Health worker reminder Other: short message(SMS) reminder Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Malaria Chemoprevention With Monthly Treatment With Dihydroartemisinin-Piperaquine for the Post-discharge Management of Severe Anaemia in Children Less Than 5 Years in Malawi
Actual Study Start Date : March 24, 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Malaria

Arm Intervention/treatment
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
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
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

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
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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

  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721420


Contacts
Layout table for location contacts
Contact: Kamija Phiri, PhD +265999957048 kphiri@medcol.mw
Contact: Thandile Nkosi-Gondwe, MBBS +265995508830 tgondwe@medcol.mw

Locations
Layout table for location information
Malawi
College Of Medicine,Training and Research Unit Of Excellence,Zomba Central Hospital Recruiting
Zomba, Malawi, 0000
Contact: Thandile Nkosi-Gondwe, MBBS    +265995508830    tgondwe@medcol.mw   
Contact: Kamija Phiri, PhD    +265999957048    kphiri@medcol.mw   
Sponsors and Collaborators
University of Malawi College of Medicine
University of Bergen
The Research Council of Norway
Makerere University
Liverpool School of Tropical Medicine
Kenya Medical Research Institute
University of Amsterdam
Imperial College London
London School of Hygiene and Tropical Medicine
University of Minnesota
Ministry of Health and Population, Malawi
Ministry of Health, Malawi
Investigators
Layout table for investigator information
Principal Investigator: Kamija Phiri, PhD University of Malawi
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Malawi College of Medicine
ClinicalTrials.gov Identifier: NCT02721420    
Other Study ID Numbers: P.02/15/1679
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Anemia
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Piperaquine
Dihydroartemisinin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents