NCT01456858

Brief Summary

A Phase III malaria prevention trial was conducted in two camps of Liberian refugees in Sierra Leone using Insecticide Treated Polyethylene Sheeting (ITPS) or untreated polyethylene sheeting (UPS) randomly deployed to defined sectors of each camp. The ITPS was impregnated with pyrethroid insecticide during manufacture. In Largo camp the ITPS or UPS was attached to inner walls and ceilings of shelters, while in Tobanda the ITPS or UPS was used to line the ceiling and roof only. Cohorts of children up to 3 years of age were cleared of malaria parasites and monitored for up to 8 months post construction for possible malaria re-infection. Installation teams and refugee groups were blinded as to whether the sheeting was insecticide treated or not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
Last Updated

October 21, 2011

Status Verified

November 1, 2003

Enrollment Period

7 months

First QC Date

October 19, 2011

Last Update Submit

October 20, 2011

Conditions

Malaria

Keywords

Malaria Prevention Refugee EmergencyMalaria, Falciparum C03.752.530.650

Outcome Measures

Primary Outcomes (1)

  • Malaria Incidence

    The primary outcome was the malaria incidence rate between children in each study arm (ITPS V's UPS) in each refugee camp. Between Dec 2003 and July 2004, daily monitoring of children in both camps was conducted from health screening points. Any child presenting with fever or reported fever in the last 24 hours was administered a clinical questionnaire based on the Integrated Management of Childhood Illness (IMCI), after which a RDT was taken to confirm malaria positivity. Malaria incidence rate was estimated as the total number of malaria episodes per person year over the course of the trial.

    8 months

Secondary Outcomes (2)

  • Anaemia (From Haemoglobin levels)

    8 months

  • Adverse Event to ITPS

    8 Months

Study Arms (4)

Child UPS Largo Camp

PLACEBO COMPARATOR

Children 4months-36months enrolled who resided in Largo refugee camp under Untreated plastic sheeting (interior wall and ceiling lining)

Other: Untreated Plastic Sheeting

Child ITPS Largo Camp

EXPERIMENTAL

Children 4months-36months enrolled who resided in Largo refugee camp under Insecticide treated plastic sheeting (interior wall and ceiling lining)

Other: Insecticide Treated Polyethylene Sheeting

Child UPS Tobanda Camp

PLACEBO COMPARATOR

Children 4months-36months enrolled who resided in Tobanda refugee camp under Untreated plastic sheeting (ceiling and interior roof lining)

Other: Untreated Plastic Sheeting

Child ITPS Tobanda Camp

EXPERIMENTAL

Children 4months-36months enrolled who resided in Tobanda refugee camp under Insecticide treated plastic sheeting (ceiling and interior roof lining)

Other: Insecticide Treated Polyethylene Sheeting

Interventions

Insecticide Treated Polyethylene SheetingOTHER

Insecticide Treated Polyethylene Sheeting is based on the standard polyethylene sheeting that is issued routinely as temporary shelter for people affected by emergencies. During manufacture the pyrethroid insecticide, deltamethrin, is extruded with the polyethylene into three-ply laminated sheets, comprising an inner low-density laminate and two, outer high-density laminates. The insecticide release characteristics enable the deltamethrin to diffuse slowly to the outer surfaces and to become available for pick-up by any insect that lands on the surface.

Also known as: Zerofly
Child ITPS Largo CampChild ITPS Tobanda Camp
Untreated Plastic SheetingOTHER

Standard polyethylene sheeting that is issued routinely as temporary shelter for people affected by emergencies. Standard untreated plastic sheeting is Identical to ITPS but without the incorporation of insecticide.

Child UPS Largo CampChild UPS Tobanda Camp

Eligibility Criteria

Age4 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Resident of LARGO or TOBANDA Refugee Camp, Sierra Leone, West Africa
  • Child whose guardian has given informed consent for their child to be enrolled into monitoring
  • Child aged 4 months to 3 years

You may not qualify if:

  • Residents who answer "Yes" to the question, "Do you anticipate/plan on moving out of this shelter or camp in the next 6-12 months?"
  • Children who have a serious illness other than malaria, based on guardian report.
  • Children who have experienced adverse reactions to Amodiaquine or Artesunate on a previous occasion.
  • Guardians of children who answer "Yes" to the question, "Do you anticipate/plan on moving out of this shelter or camp in the next 12 months?"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Mentor Initiative

Freetown, Sierra Leone

Location

Related Publications (5)

  • Graham K, Mohammad N, Rehman H, Nazari A, Ahmad M, Kamal M, Skovmand O, Guillet P, Allan R, Zaim M, Yates A, Lines J, Rowland M. Insecticide-treated plastic tarpaulins for control of malaria vectors in refugee camps. Med Vet Entomol. 2002 Dec;16(4):404-8. doi: 10.1046/j.1365-2915.2002.00395.x.

    PMID: 12510893RESULT

  • Diabate A, Chandre F, Rowland M, N'guessan R, Duchon S, Dabire KR, Hougard JM. The indoor use of plastic sheeting pre-impregnated with insecticide for control of malaria vectors. Trop Med Int Health. 2006 May;11(5):597-603. doi: 10.1111/j.1365-3156.2006.01605.x.

    PMID: 16640611RESULT

  • Djenontin A, Chabi J, Baldet T, Irish S, Pennetier C, Hougard JM, Corbel V, Akogbeto M, Chandre F. Managing insecticide resistance in malaria vectors by combining carbamate-treated plastic wall sheeting and pyrethroid-treated bed nets. Malar J. 2009 Oct 20;8:233. doi: 10.1186/1475-2875-8-233.

    PMID: 19843332RESULT

  • Chandre F, Dabire RK, Hougard JM, Djogbenou LS, Irish SR, Rowland M, N'guessan R. Field efficacy of pyrethroid treated plastic sheeting (durable lining) in combination with long lasting insecticidal nets against malaria vectors. Parasit Vectors. 2010 Aug 3;3(1):65. doi: 10.1186/1756-3305-3-65.

    PMID: 20682050RESULT

  • Djenontin A, Chandre F, Dabire KR, Chabi J, N'guessan R, Baldet T, Akogbeto M, Corbel V. Indoor use of plastic sheeting impregnated with carbamate combined with long-lasting insecticidal mosquito nets for the control of pyrethroid-resistant malaria vectors. Am J Trop Med Hyg. 2010 Aug;83(2):266-70. doi: 10.4269/ajtmh.2010.10-0012.

    PMID: 20682865RESULT

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Matthew R Burns, BSc MSc PhD viva pending

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 21, 2011

Study Start

December 1, 2003

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

October 21, 2011

Record last verified: 2003-11

Locations

SI(1)