Evaluation of Combined Use of ITN's and Insect Repellents Against Malaria

This study has been completed.
Sponsor:
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00144716
First received: September 2, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

Insecticide Treated Nets (ITN's) offer good protection against malaria in Africa where the vector mosquitoes feed indoors late at night. However, in other parts of the world like South America, vectors feed earlier in the evening before people go to bed. In such cases it may be necessary to use alternative treatments in the evening to supplement the efficacy of ITN's. This study compares 2 matched groups of households in the Bolivian Amazon. One group will be given ITN's plus a plant-based insect repellent in the evening, the other has ITN's plus a placebo lotion. Households are monitored over a full malaria season to record numbers of malaria cases.


Condition Intervention Phase
Malaria
Device: Insect Repellent plus Insecticide Treated Net
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of Combined Use of ITN's and Plant-Based Insect Repellent Against Malaria in the Amazon

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • Reduction in cases of malaria

Secondary Outcome Measures:
  • Reduction in all-cause fevers

Estimated Enrollment: 4250
Study Start Date: June 2003
Estimated Study Completion Date: October 2003
Detailed Description:

There is little doubt that the use of insecticide treated bed nets (ITN’s) is one of the most successful means of reducing malaria in Africa. However, vectors in this region tend to be late night, indoor feeders. Vector species in other parts of the world may not be so susceptible to this form of vector control. In much of Central & Southern America, the major vectors such as An. darlingi and An. albitarsis have a feeding peak between 8 – 10pm, before most people retire to bed. Similarly, the major vector in much of S.E. Asia, An. dirus, seldom enters homes to feed. In these circumstances it is unlikely ITN’s alone will provide adequate protection. Supplemental use of skin applied insect repellents may be an effective method of personal protection in the hours between dusk and retiring to bed. It would also prove useful for those individuals working late or moving early into the forest where exophagic species are encountered. As yet, there have been no robust clinical evaluations of combined ITN and repellent use. This double blind, placebo-controlled study is designed to evaluate the efficacy of combined ITN and plant based insect repellent use to reduce P. falciparum in the Bolivian Amazon in a region where ITN’s alone are likely to be ineffective.

The study is a double-blind, placebo-controlled clinical evaluation. 1000 households will be used and 5 individuals age 10 + will be entered into the study from each. Recruitment will cover all rural communities in Vaca Diez and Pando Provinces, Department of Beni in the Bolivian Amazon Region, plus the outer 10 % of periurban districts of the 2 major towns in the region, Riberalta and Guayaramerin. A maximum of 20 % of households in any one location will be used, thus avoiding any effect of diversion of insects from treatment to placebo homes. Likewise, each house used will be a minimum of 25m from any other in the study. Baseline surveys will be conducted on each individual and informed written consent will be collected. Treatment (30 % L.E.) / placebo (0.1 % clove oil in alcohol) marked A or B will be allocated (50:50) at random, and all individuals in both groups will be provided with an ITN. Compliance questionnaires, collection of old bottles and distribution of fresh bottles will be conducted every 4 weeks. Everyone will receive personal instruction on how to apply repellent to arms & legs each evening at dusk and left a pictorial instruction sheet on how to measure 10 ml using the bottle lid. Compliance threshold will be set at 10% and monitored by measuring any residual product on collection and recording of nightly use. A more realistic measure of compliance will be gained through occasional evening spot checks of households by the local health workers. Finger prick blood samples will be collected at baseline and monthly throughout the study by trained & approved field staff. P. falciparum infection will be diagnosed by Paracheck® dipstick test, thus overcoming problems of recrudescence of P. vivax. Positive cases will be referred to the local health centre for treatment. The timing of the visits means the majority of malaria episodes will be detected as the Paracheck® test can detect antibodies in blood for around 3 weeks post treatment. In addition to the use of our monthly questionnaires, any episodes missed are highly likely to be recorded, as we are employing the same local health workers in each area, and blood slides are routinely taken at the local health centres. Outcome determination will constitute a series of monthly cross-sectional prevalence surveys, and, as positive cases are treated, this is equivalent to a measure of average prevalence of infection for each house.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent.
  • Available for 4 x monthly follow ups.
  • 5 or more individuals in household.

Exclusion Criteria:

  • Allergy to repellents / plants.
  • Malaria positive at baseline.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144716

Sponsors and Collaborators
Gates Malaria Partnership
Investigators
Principal Investigator: Nigel Hill, PhD London School of Hygiene and Tropical Medicine
  More Information

No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00144716     History of Changes
Other Study ID Numbers: ITDCVG30
Study First Received: September 2, 2005
Last Updated: September 2, 2005
Health Authority: Bolivia: Ministry of Health

Keywords provided by Gates Malaria Partnership:
Vector Control
repellent
ITN's
malaria
Amazon

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Insect Repellents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014