Research paper for medical peer review journal. The paper is half written but need to be completed and be coherent. It will go to top journal in the field so experience writer only.
Protocol Version 1
A field trial of co-administration of azithromycin and ivermectin mass drug administration (MDA)
VERSION 01 June 2nd 2015
This document is confidential and the property of Murdoch Childrens Research Institute. No part of it may be transmitted reproduced published or used without prior written authorization from
STATEMENT OF COMPLIANCE
This document is a protocol for a clinical research study. The study will be conducted in compliance with all stipulations of this protocol the conditions of ethics committee approval the NHMRC
National Statement on Ethical Conduct in Human Research (2007) and the Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95
Title A field trial of co-administration of azithromycin and ivermectin mass drug administration (MDA)
Objectives Primary Aims:
To assess the feasibility of conducting a joint MDA for trachoma and scabies control in a large population.
1. To assess the safety of co-administration of azithromycin and ivermectin MDA for trachoma and scabies control.
2. To assess the efficacy of MDA for scabies and impetigo control in large island population
Design A prospective community intervention trial to assess the feasibility safety and efficacy of MDA for trachoma and scabies control in Choiseul province of the Solomon Islands.
Outcomes The primary outcome is the coverage of the MDA in the study population separate for trachoma and scabies MDA.
The secondary outcomes are: 1) the incidence of serious illness and deaths occurring in the study population in the 3 month period after MDA compared to the 3 months prior; 2) the proportion of
people self-reporting adverse events following receipt of the MDA drugs compared to previously reported rates for the agents; 3) the prevalence of scabies and impetigo at 12 months after MDA in 10
randomly selected villages compared to the prevalence at baseline (day 1) in 10 independent randomly selected villages; 4) the incidence of patients attending health clinics in Choiseul province
for skin disease related consultations.
Study Duration 1 year
Interventions Participants will be invited to take part in a joint MDA program for trachoma and scabies with the first trachoma MDA dose at the same time as the first of two scabies MDA doses.
Trachoma MDA: Participants will be offered 1 dose of azithromycin (directly observed) at 20 mg/kg up to a maximum of 1 gm. Pregnant women will be offered a choice of azithromycin or topical
tetracycline. Individuals aged less than 6 months will be offered topical tetracycline.
Scabies MDA: Participants will be offered 2 doses of oral ivermectin (directly observed) at 200 g/kg 7 days apart. Participants for whom ivermectin is contra-indicated will be offered 2 doses of
topical permethrin cream 7 days apart.
Number of subjects Approximately 26000 people
Population All individuals living in Choiseul province who agree to participate.
GLOSSARY OF ABBREVIATIONS
AE Adverse Events
NCCDC National Centre for Communicable Disease Control
MCRI Murdoch Childrens Research Institute
LSHTM London School of Hygiene & Tropical Medicine
MDA Mass Drug Administration
MHMS Ministry of Health and Medical Services
NHMRC National Health and Medical Research Council
NTD Neglected Tropical Diseases
SAE Serious Adverse Events
SOP Standard Operating Procedures
SSTI Skin and Soft Tissue Infections
UNSW University of New South Wales
WHO World Health Organization
1. INVESTIGATORS AND FACILITIES
1.1 Study Locations
Choiseul Province is one of ten provinces of the Solomon Islands and has a total population of approximately 26000 people. The province consists of 14 wards. Health care is provided by 17 nurse
aid posts 10 rural health clinics 1 area health centre and 2 hospitals. In 2014 the Solomon Islands government began implementing MDA for trachoma in 9 out of its ten provinces as part of the WHO
SAFE strategy.1 Following a recent regional trachoma meeting the government recently decided to complete the national coverage by adding the province of Choiseul.
Figure 1. Communities chosen for the study
1.2 Study Management
The trial will be coordinated by a research team led by the principal investigator a study doctor and a study coordinator. Informed consent discussions and clinical assessments will be conducted
by trained nursing study staff the study doctor and the study coordinator. The study coordinator will be delegated responsibility for subjects follow-up visits data collection and maintenance of
study documentation. Handling of investigational products will be the responsibility of the study coordinator under supervision from the Principal investigator.