- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07838701
Efficacy and Safety of Indoor Residual Spray for Dengue Vector Control
This quasi-experimental interventional study was conducted over 1 year, from May 2024-May 2025 at Station Health Organization, Combined Military Hospital, Peshawar Cantonment. Two comparable localities in Peshawar Cantonment were selected based on previous dengue incidence reports. Non-Probability consecutive sampling technique was used. Prior approval was sought from Station Commander, Station Headquarters Peshawar to conduct the study in Peshawar Cantonment. Hospital ethical review certificate was obtained (vide CMH Peshawar Letter No: 00254/25). Written informed consent was taken from the participants for inclusion in the study. One locality was designated as the intervention area (Indoor Residual Spray applied), and the other as the control area (Indoor Residual Spray not applied). Households were selected using a non-probability consecutive sampling technique.
In the intervention area, indoor residual spraying was conducted using Deltamethrin 2.5% WP, following WHO guidelines. Spray teams were trained and monitored to ensure proper application on interior walls, dark corners, and mosquito resting sites. Spraying was repeated every three months.
Entomological surveys were conducted at baseline and monthly thereafter in both areas, using larval/pupal indices (House Index and Breteau Index). Adult mosquito density was measured using backpack aspirators and resting catches. Dengue case data was collected by the Station Health Organization from CMH Peshawar and cross-checked with the Pathology department of the same hospital. The study was conducted as pilot study of the organization.
Data was analyzed using Statistical Pacakage for Social Sceinces version 27. Mean mosquito density, larval indices, and dengue incidence were compared between intervention and control areas using paired t-test. A p-value < 0.05 was considered statistically significant.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Khyber Pakhtunkhwa
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Peshawar, Khyber Pakhtunkhwa, Pákistán, 25000
- Station Health Organization C/O Combined Military Hospital Peshawar
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Households consenting to participate and allow entomological inspections.
- Permanent residents with no history of shifting during the study period.
Exclusion Criteria:
- Houses under construction or vacant.
- If any resident of the household had prior history of allergic reaction to the sprayed chemicals.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: IRS Area
100 households were inducted in the IRS Arms |
In the intervention area, indoor residual spraying was conducted using Deltamethrin 2.5% WP, following WHO guidelines. Spray teams were trained and monitored to ensure proper application on interior walls, dark corners, and mosquito resting sites. Spraying was repeated every three months. |
|
Žádný zásah: Control Area
100 households were inducted in the Control Arm |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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To assess the safety of indoor residual spray in terms of participants reported adverse side effects after the use of spray ; both immediate and up to 3 months folllow up
Časové okno: 3 months follow up to asses the safety of indoor residual spray
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To assess the safety of indoor residual spray in terms of participants reported adverse side effects after the use of spray ; both immediate and up to 3 months folllow up. Patients will report any adverse effects to the investigator, including rhinitis, skin rash, urticaria or any other newer finding noticed by the participant. |
3 months follow up to asses the safety of indoor residual spray
|
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To assess the efficacy of indoor residual spray using House Index
Časové okno: 3 months follow-up to assess the efficacy of indoor residual spray to kill the mosquitoes using changes in House Index.
|
The Efficacy of indoor residual spray was assessed using House Index. House Index was compared for interventional area where the indoor residual spray was performed and the control area which was intervention naive. The baseline and 3 months follow up indices were compared to ascertain the efficacy of intervention. The House Index (HI) is the percentage of inspected houses that have mosquito larvae or pupae in or around them |
3 months follow-up to assess the efficacy of indoor residual spray to kill the mosquitoes using changes in House Index.
|
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The Efficacy of indoor residual spray was assessed using Bretau Index.
Časové okno: The baseline and 3-month follow-up indices were compared to ascertain the efficacy of intervention.
|
The Efficacy of indoor residual spray was assessed using Bretau Index. Bretau Index was compared for interventional area where the indoor residual spray was performed and the control area which was intervention naive. Bretau Index measures mosquito vector density by tracking the number of positive water-holding containers per 100 houses inspected |
The baseline and 3-month follow-up indices were compared to ascertain the efficacy of intervention.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Bowman LR, Donegan S, McCall PJ. Is Dengue Vector Control Deficient in Effectiveness or Evidence?: Systematic Review and Meta-analysis. PLoS Negl Trop Dis. 2016 Mar 17;10(3):e0004551. doi: 10.1371/journal.pntd.0004551. eCollection 2016 Mar.
- Gubler DJ. The global emergence/resurgence of arboviral diseases as public health problems. Arch Med Res. 2002 Jul-Aug;33(4):330-42. doi: 10.1016/s0188-4409(02)00378-8.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 00254/25
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Study protocol and statistical data analysis sheet/ methods will be shraed upon request
Časový rámec sdílení IPD
15 Sep 2026 to 15 Jun 2027
Kritéria přístupu pro sdílení IPD
Upon request, any one associated with heathcare system may be able to accesss the study protocol and any statistical data analysis format
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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