Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02329301
Other study ID # PATH-WIRB-20140824
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date August 2020

Study information

Verified date September 2020
Source PATH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2430
Est. completion date August 2020
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Months and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MDA with DHAp (Eurartesim)
Eurartesim is the brand name.
Focal MDA with DHAp (Eurartesim)
Eurartesim is the brand name.

Locations

Country Name City State
Zambia Southern province medical office Choma Southern

Sponsors (4)

Lead Sponsor Collaborator
PATH Minister of Community Development, Mother and Child Health, Zambia, Ministry of Health, Zambia, Tulane University

Country where clinical trial is conducted

Zambia, 

References & Publications (11)

Alonso PL. The Role of Mass Drug Administration of Antimalarials. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):1-2. doi: 10.4269/ajtmh.20-0729. — View Citation

Bennett A, Porter TR, Mwenda MC, Yukich JO, Finn TP, Lungu C, Silumbe K, Mambwe B, Chishimba S, Mulube C, Bridges DJ, Hamainza B, Slutsker L, Steketee RW, Miller JM, Eisele TP. A Longitudinal Cohort to Monitor Malaria Infection Incidence during Mass Drug Administration in Southern Province, Zambia. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):54-65. doi: 10.4269/ajtmh.19-0657. — View Citation

Chishimba S, Mwenda M, Mambwe B, Mulube C, Chalwe V, Moonga H, Hamainza B, Chizema-Kawesha E, Steketee RW, Domingo G, Fraser M, Kahn M, Pal S, Silumbe K, Conner RO, Bennett A, Porter TR, Eisele TP, Miller JM, Bridges DJ. Prevalence of Plasmodium falciparum and Non-falciparum Infections by Photo-Induced Electron Transfer-PCR in a Longitudinal Cohort of Individuals Enrolled in a Mass Drug Administration Trial in Southern Province, Zambia. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):82-89. doi: 10.4269/ajtmh.19-0668. — View Citation

Eisele TP, Bennett A, Silumbe K, Finn TP, Chalwe V, Kamuliwo M, Hamainza B, Moonga H, Kooma E, Chizema Kawesha E, Yukich J, Keating J, Porter T, Conner RO, Earle D, Steketee RW, Miller JM. Short-term Impact of Mass Drug Administration With Dihydroartemisinin Plus Piperaquine on Malaria in Southern Province Zambia: A Cluster-Randomized Controlled Trial. J Infect Dis. 2016 Dec 15;214(12):1831-1839. Erratum in: J Infect Dis. 2017 Nov 15;216(8):1048. — View Citation

Eisele TP, Bennett A, Silumbe K, Finn TP, Porter TR, Chalwe V, Hamainza B, Moonga H, Kooma E, Chizema Kawesha E, Kamuliwo M, Yukich JO, Keating J, Schneider K, Conner RO, Earle D, Slutsker L, Steketee RW, Miller JM. Impact of Four Rounds of Mass Drug Administration with Dihydroartemisinin-Piperaquine Implemented in Southern Province, Zambia. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):7-18. doi: 10.4269/ajtmh.19-0659. — View Citation

Eisele TP, Silumbe K, Finn T, Chalwe V, Kamuliwo M, Hamainza B, Moonga H, Bennett A, Yukich J, Keating J, Steketee RW, Miller JM. Assessing the effectiveness of household-level focal mass drug administration and community-wide mass drug administration for reducing malaria parasite infection prevalence and incidence in Southern Province, Zambia: study protocol for a community randomized controlled trial. Trials. 2015 Aug 13;16:347. doi: 10.1186/s13063-015-0862-3. — View Citation

Finn TP, Porter TR, Moonga H, Silumbe K, Daniels RF, Volkman SK, Yukich JO, Keating J, Bennett A, Steketee RW, Miller JM, Eisele TP. Adherence to Mass Drug Administration with Dihydroartemisinin-Piperaquine and Plasmodium falciparum Clearance in Southern Province, Zambia. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):37-45. doi: 10.4269/ajtmh.19-0667. — View Citation

Finn TP, Yukich JO, Bennett A, Porter TR, Lungu C, Hamainza B, Chizema Kawesha E, Conner RO, Silumbe K, Steketee RW, Miller JM, Keating J, Eisele TP. Treatment Coverage Estimation for Mass Drug Administration for Malaria with Dihydroartemisinin-Piperaquine in Southern Province, Zambia. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):19-27. doi: 10.4269/ajtmh.19-0665. — View Citation

Miller JM, Eisele TP, Fraser MS, Lewis MT, Slutsker L, Chizema Kawesha E. Moving from Malaria Burden Reduction toward Elimination: An Evaluation of Mass Drug Administration in Southern Province, Zambia. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):3-6. doi: 10.4269/ajtmh.19-0669. — View Citation

Silumbe K, Finn TP, Jennings T, Sikombe C, Chiyende E, Hamainza B, Chizema Kawesha E, Eisele TP, Earle D, Steketee RW, Miller JM. Assessment of the Acceptability of Testing and Treatment during a Mass Drug Administration Trial for Malaria in Zambia Using Mixed Methods. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):28-36. doi: 10.4269/ajtmh.19-0663. — View Citation

Yukich JO, Scott C, Silumbe K, Larson BA, Bennett A, Finn TP, Hamainza B, Conner RO, Porter TR, Keating J, Steketee RW, Eisele TP, Miller JM. Cost-Effectiveness of Focal Mass Drug Administration and Mass Drug Administration with Dihydroartemisinin-Piperaquine for Malaria Prevention in Southern Province, Zambia: Results of a Community-Randomized Controlled Trial. Am J Trop Med Hyg. 2020 Aug;103(2_Suppl):46-53. doi: 10.4269/ajtmh.19-0661. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Population coverage of the fMDA and MDA interventions at each round Population coverage of the fMDA and MDA interventions at each round For up to 4 months
Primary Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month) Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month) For up to 12 months
Primary P.falciparum infection incidence rate among individuals =3 months P.falciparum infection incidence rate among individuals =3 months For up to 12 months
Secondary Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages For up to 48 months (including retrospectively)
Secondary Malaria rapid diagnostic test test positivity rate from focal mass drug administration (fMDA) and mass drug administration (MDA) interventions (plus control group) Malaria rapid diagnostic test test positivity rate from focal mass drug administration (fMDA) and mass drug administration (MDA) interventions (plus control group) For up to 10 months
See also
  Status Clinical Trial Phase
Completed NCT04601714 - Baseline Cohort Malaria Morbidity Study
Withdrawn NCT04020653 - A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria Phase 2
Terminated NCT04368910 - Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria Phase 3
Completed NCT03641339 - Defining Skin Immunity of a Bite of Key Insect Vectors in Humans N/A
Completed NCT02544048 - Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
Completed NCT00527163 - Role of Nitric Oxide in Malaria
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Active, not recruiting NCT04704674 - Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
Completed NCT03276962 - Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age Phase 2
Completed NCT04966871 - Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults Phase 1
Completed NCT00289185 - Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants Phase 2
Recruiting NCT03937817 - Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Active, not recruiting NCT06153862 - Africa Ready Malaria Screening N/A
Completed NCT04545905 - Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
Recruiting NCT06278181 - Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
Completed NCT02793622 - Prevention of Malaria in HIV-uninfected Pregnant Women and Infants Phase 3
Withdrawn NCT02793388 - A Trial on Supervised Primaquine Use in Ethiopia Phase 4
Completed NCT02909712 - Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania Phase 2
Withdrawn NCT02793414 - Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
Completed NCT02315690 - Evaluation of Reactive Focal Mass Drug Administration for Malaria Elimination in Swaziland Phase 3