MalariaNCT02329301
Mass Drug Administration With Dihydroartemisinin + Piperaquine for Reducing Malaria in Southern Zambia
A study testing MDA with DHAp (Eurartesim) and Focal MDA with DHAp (Eurartesim) in people with Malaria and Malaria, Falciparum, run by PATH at 1 site in Zambia.
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… Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria, Malaria, Falciparum
- What is being tested?
- MDA with DHAp (Eurartesim) and Focal MDA with DHAp (Eurartesim)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,430 participants
- Where
- 1 siteZambia
- Study dates
- Sep 2014to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- anyone not excluded and consenting
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effectiveness of Mass Drug Administration (MDA) With Dihydroartemisinin + Piperaquine for Reducing Malaria Parasite Infection Prevalence and Incidence in Southern Province Zambia
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.
Read the 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:
- 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;
- 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;
- 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;
- 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;
- 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;
- 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
- 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:
- Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month)
- Pf infection incidence rate among individuals ≥3 months
- Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages
- RDT test positivity rate from fMDA and MDA interventions (plus control group)
- 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.
- Conditions
- Malaria, Malaria, Falciparum
- Being tested
- MDA with DHAp (Eurartesim), Focal MDA with DHAp (Eurartesim)
- Keywords
- malaria, malaria, falciparum, antimalarials
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDA with DHAp (Eurartesim)Drug
Also called mass drug administration with DHAp
Eurartesim is the brand name.
Focal MDA with DHAp (Eurartesim)Drug
Also called focal mass drug administration with DHAp
Eurartesim is the brand name.
| Study group | Role | What they receive |
|---|---|---|
| MDA with DHAp (Eurartesim) | Experimental | 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. Receives: Drug: MDA with DHAp (Eurartesim) |
| Focal MDA with DHAp (Eurartesim) | Experimental | 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. Receives: Drug: Focal MDA with DHAp (Eurartesim) |
| Standard of Care (Control) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: For up to 12 months
P.falciparum infection incidence rate among individuals ≥3 months
P.falciparum infection incidence rate among individuals ≥3 months
Measured: For up to 12 months
Secondary outcomes (2)
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
Measured: For up to 48 months (including retrospectively)
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)
Measured: For up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,430 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Zambia, Minister of Community Development, Mother and Child Health, Zambia, Tulane University
- Responsible party
- Sponsor
- Investigators
- John M Miller, PhD, Principal investigator, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329301
- Sponsor's protocol ID
- PATH-WIRB-20140824
- Status last verified
- Sep 2020
- First submitted
- 13 Nov 2014
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26268804Eisele 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. doi: 10.1093/infdis/jiw416.
PubMed 27923947Alonso 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. No abstract available.
PubMed 32618264Eisele 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.
PubMed 32618247Yukich 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.
PubMed 32618249Finn 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.
PubMed 32618267Finn 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.
PubMed 32618251Silumbe 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.
PubMed 32618242Miller 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.
PubMed 32618265Bennett 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.
PubMed 32618245Chishimba 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.
PubMed 32618252Shah MP, Hwang J, Choi L, Lindblade KA, Kachur SP, Desai M. Mass drug administration for malaria. Cochrane Database Syst Rev. 2021 Sep 29;9(9):CD008846. doi: 10.1002/14651858.CD008846.pub3.
PubMed 34585740
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Mass Drug Administration (MDA) With Dihydroartemisinin + Piperaquine for Reducing Malaria Parasite Infection Prevalence and Incidence in Southern Province Zambia
- ClinicalTrials.gov ID
- NCT02329301
- Acronym / sponsor ID
- PATH-WIRB-20140824
- Conditions
- Malaria, Malaria, Falciparum
- Keywords
- malaria, malaria, falciparum, antimalarials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,430 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Ministry of Health, Zambia, Minister of Community Development, Mother and Child Health, Zambia, Tulane University
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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;
- 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;
- 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;
- 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;
- 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
- 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:
- Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month)
- Pf infection incidence rate among individuals ≥3 months
- Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages
- RDT test positivity rate from fMDA and MDA interventions (plus control group)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MDA with DHAp (Eurartesim) | Experimental | Drug: 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. |
| Focal MDA with DHAp (Eurartesim) | Experimental | Drug: 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. |
| Standard of Care (Control) | No intervention | –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. |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- anyone not excluded and consenting
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDA with DHAp (Eurartesim)Also: mass drug administration with DHApEurartesim is the brand name. | Drug | MDA with DHAp (Eurartesim) |
| Focal MDA with DHAp (Eurartesim)Also: focal mass drug administration with DHApEurartesim is the brand name. | Drug | Focal MDA with DHAp (Eurartesim) |
Primary outcome
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
2 secondary outcomes
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 26268804Eisele 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.
- Background: PubMed 27923947Eisele 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. doi: 10.1093/infdis/jiw416.
- Background: PubMed 32618264Alonso 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. No abstract available.
- Background: PubMed 32618247Eisele 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.
- Background: PubMed 32618249Yukich 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.
- Background: PubMed 32618267Finn 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.
- Background: PubMed 32618251Finn 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.
- Background: PubMed 32618242Silumbe 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.
- Background: PubMed 32618265Miller 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.
- Background: PubMed 32618245Bennett 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.
- Background: PubMed 32618252Chishimba 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.
- Derived from this study: PubMed 34585740Shah MP, Hwang J, Choi L, Lindblade KA, Kachur SP, Desai M. Mass drug administration for malaria. Cochrane Database Syst Rev. 2021 Sep 29;9(9):CD008846. doi: 10.1002/14651858.CD008846.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Miller, PhD principal investigator
PATH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MDA with DHAp (Eurartesim) and Focal MDA with DHAp (Eurartesim) in people with Malaria and Malaria, Falciparum, run by PATH at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month) (time frame: For up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02329301, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.