Table 2 Trial registration data
Data category | Information |
|---|---|
Primary registry and trial identification number | ClinicalTrials.gov, ID: NCT03036059 |
Date of registration in primary registry | 26 January 2017 |
Secondary identifying numbers | Ghana Health Service Ethics Review Committee: 04112/2016 Noguchi Memorial Institute for Medical Research IRB: CPN 062/16-17 |
Source(s) of monetary or material support | EDCTP grant TMA 2015 CDF - 976 |
Primary sponsor | Noguchi Memorial Institute for Medical Research |
Contact for public queries | DKdS |
Contact for scientific queries | DKdS, CSA, SAA |
Public title | Twice Yearly Treatment for the Control of LF |
Scientific title | Cluster Randomised Community-based Trial of Annual Versus Biannual Single-dose Ivermectin Plus Albendazole Against Wuchereria Bancrofti Infection in Human and Mosquito Populations |
Country of recruitment | Ghana |
Health condition(s) or problem(s) studied | Lymphatic filariasis |
Interventions | 400 μg/kg ivermectin + 400 mg albendazole tablets given once or twice a year |
Key inclusion and exclusion criteria | Inclusion criteria: residency in endemic community for at least 12Â months; willingness to provide informed consent/assent; willingness to donate blood (per the protocol) Exclusion criteria: recent residents (<12Â months) in the study districts; inability to give informed consent due to illness, serious medical problems or refusal to participate in the study; pregnancy; children below the age of 5Â years |
Study type | Interventional allocation: randomised Masking: no masking, open label |
Date of first enrolment | 19 May 2017 |
Target sample size | 1440 |
Recruitment status | Recruiting |
Primary outcome(s) | Change from baseline prevalence of lymphatic filariasis at 12, 24 and 30Â months |
Key secondary outcome(s) | Longitudinal assessment of transmission dynamics of lymphatic filariasis. Evaluation of community acceptability of twice-yearly treatment. Feasibility of scale-up of twice-yearly treatment |