NCT02533336

Brief Summary

Over one year period in an area with universal coverage of LLIN and ACT provision as the first-line treatment of malaria, the investigators intend to evaluate the impact of DL on malaria transmission as measured by the incidence of malaria parasitemia, the prevalence of moderate to severe anemia, and entomological parameters. Information on the relative cost-effectiveness estimates of DL and the community acceptability of DL will also be measured.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,917

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2014

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

November 9, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

July 13, 2014

Last Update Submit

February 4, 2019

Conditions

Malaria

Keywords

Malaria controlInsecticide treated durable Wall LinersMalaria incidenceRandomized Trial

Outcome Measures

Primary Outcomes (1)

  • Incidence of malaria parasitemia

    The primary end point of the study is the cumulative incidence of malaria parasitaemia (asymptomatic or symptomatic) defined as the number of mRDT-confirmed episodes of parasitaemia per person-year

    1 year

Secondary Outcomes (1)

  • Effectiveness of DL on anemia

    1 year

Study Arms (2)

DL+LLINs

EXPERIMENTAL

DL treated with abamectin and fenpyroximate

Drug: abamectin and fenpyroximate

LLINs

NO INTERVENTION

LLINs only

Interventions

abamectin and fenpyroximateDRUG
DL+LLINs

Eligibility Criteria

Age6 Months - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Permanent residence in a selected household
  • Aged 6 months- 11years for cohort study
  • Informed parental consent
  • For children between 8-11 years old, written assent

You may not qualify if:

  • Severely ill and unlikely to be able to complete the study
  • Family does not intend to remain in the study area during the study period, or through the long rains
  • Household does not accept intervention
  • Not living in the study area when interventions were implemented
  • enrolled in other interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muheza

Tanga, Muheza, 255, Tanzania

Location

Related Publications (2)

  • Mpangala KR, Halasa-Rappel YA, Mohamed MS, Mnzava RC, Mkuza KJ, Mangesho PE, Kisinza WN, Mugasa JP, Messenger LA, Mtove G, Kihombo AR, Shepard DS. On the cost-effectiveness of insecticide-treated wall liner and indoor residual spraying as additions to insecticide treated bed nets to prevent malaria: findings from cluster randomized trials in Tanzania. BMC Public Health. 2021 Sep 14;21(1):1666. doi: 10.1186/s12889-021-11671-2.

    PMID: 34521374DERIVED

  • Mtove G, Mugasa JP, Messenger LA, Malima RC, Mangesho P, Magogo F, Plucinski M, Hashimu R, Matowo J, Shepard D, Batengana B, Cook J, Emidi B, Halasa Y, Kaaya R, Kihombo A, Lindblade KA, Makenga G, Mpangala R, Mwambuli A, Mzava R, Mziray A, Olang G, Oxborough RM, Seif M, Sambu E, Samuels A, Sudi W, Thomas J, Weston S, Alilio M, Binkin N, Gimnig J, Kleinschmidt I, McElroy P, Moulton LH, Norris L, Ruebush T, Venkatesan M, Rowland M, Mosha FW, Kisinza WN. The effectiveness of non-pyrethroid insecticide-treated durable wall lining to control malaria in rural Tanzania: study protocol for a two-armed cluster randomized trial. BMC Public Health. 2016 Jul 25;16:633. doi: 10.1186/s12889-016-3287-3.

    PMID: 27456339DERIVED

MeSH Terms

Conditions

Malaria

Interventions

abamectinfenpyroximate

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • William N Kisinza, PhD

    National Institute for Medical Research

    PRINCIPAL INVESTIGATOR

  • Joseph P Mugasa, PhD

    National Institute for Medical Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

July 13, 2014

First Posted

August 26, 2015

Study Start

November 9, 2015

Primary Completion

August 31, 2016

Study Completion

March 31, 2017

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

TA(1)