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Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria in Southern Zambia

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ClinicalTrials.gov Identifier: NCT02329301
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Ministry of Health, Zambia
Minister of Community Development, Mother and Child Health, Zambia
Tulane University
Information provided by (Responsible Party):
PATH

Tracking Information
First Submitted Date  ICMJE November 13, 2014
First Posted Date  ICMJE December 31, 2014
Last Update Posted Date September 16, 2020
Study Start Date  ICMJE September 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2014)
  • Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month) [ Time Frame: For up to 12 months ]
    Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month)
  • P.falciparum infection incidence rate among individuals ≥3 months [ Time Frame: For up to 12 months ]
    P.falciparum infection incidence rate among individuals ≥3 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2014)
  • Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages [ Time Frame: For up to 48 months (including retrospectively) ]
    Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages
  • Malaria rapid diagnostic test test positivity rate from focal mass drug administration (fMDA) and mass drug administration (MDA) interventions (plus control group) [ Time Frame: For up to 10 months ]
    Malaria rapid diagnostic test test positivity rate from focal mass drug administration (fMDA) and mass drug administration (MDA) interventions (plus control group)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 30, 2014)
Population coverage of the fMDA and MDA interventions at each round [ Time Frame: For up to 4 months ]
Population coverage of the fMDA and MDA interventions at each round
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria in Southern Zambia
Official Title  ICMJE Assessing the Effectiveness of Mass Drug Administration (MDA) With Dihydroartemisinin + Piperaquine for Reducing Malaria Parasite Infection Prevalence and Incidence in Southern Province Zambia
Brief Summary To quantify the relative effectiveness, cost, and cost-effectiveness of fMDA and MDA with DHAp against no mass treatment for reducing P. falciparum parasite prevalence, confirmed OPD malaria case incidence and cohort infection incidence in areas of high and low malaria transmission and in a program-relevant manner that will permit adoption and adaptation for wider-scale deployment.
Detailed Description

To quantify the relative effectiveness, cost, and cost-effectiveness of fMDA and MDA with DHAp against no mass treatment for reducing P. falciparum parasite prevalence, confirmed OPD malaria case incidence and cohort infection incidence in areas of high and low malaria transmission and in a program-relevant manner that will permit adoption and adaptation for wider-scale deployment.

In areas stratified by high and low malaria transmission, are 2 rounds of fMDA and MDA with DHAp more effective than no mass treatment (current standard of care) at reducing malaria parasite prevalence, health facility confirmed case incidence and community infection incidence over a 12 month period

  • Null hypothesis (H0): There is no benefit of 2 rounds of fMDA or MDA with DHAp over current standard of care (national policy of case management) at reducing malaria parasite prevalence, health facility confirmed case incidence and community infection incidence over a 12 month period.
  • Research hypothesis (HR): 2 rounds of fMDA and MDA with DHAp during the low transmission season will be significantly more effective than no mass treatment (standard of care) at reducing malaria parasite prevalence, health facility confirmed case incidence and community infection incidence over a 12 month period.

The research objectives are:

  1. In areas stratified by high and low malaria transmission, evaluate the relative effectiveness of 2 rounds of fMDA with DHAp (fMDA arm), 2 rounds of community-wide MDA with DHAp (MDA arm) and no mass treatment (current standard of care - control arm) on the outcomes of reducing malaria parasite prevalence, confirmed case incidence and infection incidence over a 12 month period;
  2. In areas stratified by high and low malaria transmission, assess the percent of health facility catchment areas (HFCA) with fMDA and MDA interventions that are able to reduce annual confirmed malaria case incidence to below 25 cases per 1,000 catchment population, which would permit the transition to a passive case investigation approach for malaria elimination;
  3. Quantify the population coverage of the fMDA and MDA interventions in the study areas, including the identification of systematic barriers to achieving high coverage, under best programmatic efforts using directly observed treatment (DOT) to assure full treatment;
  4. Assess and compare the cost and cost-effectiveness of fMDA and MDA with DHAp to no mass treatment in areas of high and low transmission;
  5. Assess the adherence of taking a full course of DHAp by the fMDA and MDA interventions in areas of high and low transmission, under best programmatic efforts using DOT to assure full treatment;
  6. Assess the clearance of asexual stage parasites at day 7 following the administration of DHAp under the best programmatic efforts using DOT to assure full treatment; and
  7. Assess the acceptability of participating in the fMDA and MDA interventions among community members and health care leaders in areas of high and low transmission.

The study population includes:

Population of ~560,000 people in ~112,000 households in 60 health facility catchment areas near Lake Kariba in Southern Province.

Cluster randomized controlled trial in high and low transmission areas will be used to evaluate the fMDA and MDA interventions against current standard of care for the effect on population-wide parasite prevalence (RDT and more sensitive assay), community cohort infection incidence and routinely collected confirmed malaria case incidence.

The primary outcomes are:

  1. Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month)
  2. Pf infection incidence rate among individuals ≥3 months
  3. Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages
  4. RDT test positivity rate from fMDA and MDA interventions (plus control group)
  5. Population coverage of the fMDA and MDA interventions at each round

The entire population will be included in the study; interventions will be grouped/assigned randomly according to health facility catchment area (n= 60 health facilities), matched on potential confounding factors. Household surveys in the high transmission season before and after the interventions will be used for ascertaining malaria parasite prevalence. A longitudinal cohort will be used for ascertaining the infection incidence rate. The health system rapid reporting system will be used for ascertaining confirmed malaria case incidence.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malaria
  • Malaria, Falciparum
Intervention  ICMJE
  • Drug: MDA with DHAp (Eurartesim)
    Eurartesim is the brand name.
    Other Name: mass drug administration with DHAp
  • Drug: Focal MDA with DHAp (Eurartesim)
    Eurartesim is the brand name.
    Other Name: focal mass drug administration with DHAp
Study Arms  ICMJE
  • Experimental: MDA with DHAp (Eurartesim)
    All consenting community members eligible to receive DHAp will be provided age-appropriate treatment dose of DHAp regardless of the malaria rapid diagnostic test (RDT) result. Treatment will be administered in a house-to-house campaign.
    Intervention: Drug: MDA with DHAp (Eurartesim)
  • Experimental: Focal MDA with DHAp (Eurartesim)
    All consenting household members eligible to receive DHAp and living in a household where anyone in the household tests positive with a malaria rapid diagnostic test (RDT) will receive the age-appropriate treatment dose of DHAp. If no one in the household tests RDT positive then no one in the household will receive DHAp. Treatment will be administered in a house-to-house campaign.
    Intervention: Drug: Focal MDA with DHAp (Eurartesim)
  • No Intervention: Standard of Care (Control)
    The standard of care arm will reflect no community-based treatment interventions but will have the standard of care offered by the Ministry of Health and Ministry of Community Development, Mother and Child Health which applies to all arms. This includes available mosquito net coverage, indoor residual spraying and passive case detection of individuals seeking treatment from a health provider at a clinic or health post.
Publications *

*   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: August 9, 2016)
2430
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2014)
5640
Actual Study Completion Date  ICMJE August 2020
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • anyone not excluded and consenting

Exclusion Criteria:

  • contraindications from manufacturer for medications including currently taking haloperidol, artane, Phenergan (Promethazine), chlorpromazine, erythromycin, Azithromycin, clarithromycin, Ketoconazole, fluconazole, mefloquine (as prophylaxis), lumefantrine (in Coartem), quinine, Septrin
  • anyone seriously ill
  • currently taking antimalarial medicines
  • allergy to artemisinin drugs
  • pregnant women in first trimester
  • children under 3 months of age
  • reported heart condition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Zambia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02329301
Other Study ID Numbers  ICMJE PATH-WIRB-20140824
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PATH
Study Sponsor  ICMJE PATH
Collaborators  ICMJE
  • Ministry of Health, Zambia
  • Minister of Community Development, Mother and Child Health, Zambia
  • Tulane University
Investigators  ICMJE
Principal Investigator: John M Miller, PhD PATH
PRS Account PATH
Verification Date September 2020

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