Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144716
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-02
Brief Title:
Evaluation of Combined Use of ITNs and Insect Repellents Against Malaria
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
Clinical Evaluation of Combined Use of ITNs and Plant-based Insect Repellent Against Malaria in the Amazon
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Insecticide Treated Nets ITNs 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 ITNs This study compares 2 matched groups of households in the Bolivian Amazon One group will be given ITNs plus a plant-based insect repellent in the evening the other has ITNs plus a placebo lotion Households are monitored over a full malaria season to record numbers of malaria cases
Detailed Description:
There is little doubt that the use of insecticide treated bed nets ITNs 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 SE Asia An dirus seldom enters homes to feed In these circumstances it is unlikely ITNs 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 ITNs 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 LE placebo 01 clove oil in alcohol marked A or B will be allocated 5050 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
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 LE placebo 01 clove oil in alcohol marked A or B will be allocated 5050 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None