co-administration of azithromycin and ivermectin mass drug administration (MDA)
Order Description
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
CONFIDENTIAL
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
the institution.
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
PROTOCOL SYNOPSIS
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.
Secondary Aims:
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
ABBREVIATION TERM
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.
1.2.1 Principal Investigator
Associate Professor Andrew Steer MBBS PhD
Murdoch Childrens Research Institute
Phone: +613 9345 4638
Fax: +613 9345 6667
Email: andrew.steer@rch.org.au
1.2.2 Statistician and other investigators
Statistician:
Associate Professor Handan Wand
Kirby Institute University of New South Wales
Sydney Australia
Phone: +61 2 9385 0861
Email: hwand@kirby.unsw.edu.au
Other investigators and members of the Research Team
Mr Oliver Sokana
NTD Officer
Solomon Islands Ministry of Health
Dr Titus Nasi
Paediatrician
Solomon Islands Ministry of Health
Professor John Kaldor
Epidemiologist
Kirby Institute University of New South Wales
Dr Michael Marks
Clinical Research Fellow
London School of Hygiene and Tropical Medicine
Ms Lucia Romani
Study Coordinator
Kirby Institute University of New South Wales
Dr Daniel Engelman
Paediatrician
Murdoch Childrens Research Institute
Dr Margot Whitfeld
Dermatologist
University of New South Wales
1.2.3 Internal Trial Committees
A trial steering committee will be established to provide general oversight of the trial including decisions on protocol development and protocol deviations response to issues arising throughout
trial and interpretation of findings.
1.2.4 Independent Safety and Data Monitoring Committee
An independent data and safety monitoring committee will be established to oversee the safety and progress of the trial.
1.3 Sponsor
Murdoch Childrens Research Institute
1.4 Funding and resources
Funding for the study is from Murdoch Childrens Research Institute University of New South Wales and the London School of Hygiene and Tropical Medicine.
2. INTRODUCTION AND BACKGROUND
2.1 Background Information
Mass Drug Administration
MDA for neglected tropical diseases has made a major contribution to public health across the world. Over the past two decades the MDA strategy has been adopted to treat whole populations that are
infected or at risk of infection without requiring individual diagnosis. The biological basis of MDA varies across pathogens but generally rests on the premise that the chain of transmission can
only be broken by targeting people regardless of symptoms or other evidence of the presence of infection. MDA has been highly effective in the control of several major neglected tropical diseases
and is supported by WHO and multiple partners through large regional and global programmes such as the Global Elimination of Trachoma (GET 2020) the Global Lymphatic Filariasis Elimination
Programme the Onchocerciasis Elimination Programme in the Americas and the African Programme for Onchocerciasis Control. The five pharmaceutical agents that have been particularly prominent in MDA
are ivermectin azithromycin albendazole diethylcarbamzine and praziquantel. Over 700 million people receive these essential medicines annually with ivermectin by the far the most frequently
delivered drug.
MDA in the Solomon Islands for trachoma
Trachoma is the most common infectious cause of blindness globally. It is caused by ocular infection with Chlamydia trachomatis. Transmission is favoured in poor communities where crowding is
common and access to water and sanitation inadequate. Repeated reinfection over many years causes scarring of the upper eyelid. The resultant inversion of the lashes abrades the eyeball and the
abrasion leads to corneal opacification and visual impairment. The SAFE strategy is used for the control of trachoma: surgery for inturned lashes antibiotics for active disease facial
cleanliness and environmental improvement.2
The World Health Organization (WHO) recommends that a country conduct mass drug administration with azithromycin in areas where the prevalence of trachomatous follicular inflammation (TF) is above
10% in children aged 1-9 years old. Provincial trachoma assessments were completed by the Solomon Islands Ministry of Health and Medical Services (MHMS) between 2011-13. Nine out of ten provinces
met the WHO criteria for conducting mass drug administration and this was undertaken in 2014. Choiseul was the only province in which MDA was not initially conducted.
A regional trachoma meeting was held in Suva Fiji in March 2014 attended by the WHO Fred Hollows Foundation and MHMS. Due to the small population size of several provinces in the Solomon Islands
it was agreed to form three larger evaluation units for trachoma control activities. Choiseul province was therefore included in an evaluation unit with Western province. The prevalence of TF in
this new evaluation unit was above 10% and it was therefore recommended that MHMS conduct MDA in Choiseul province.
The problem of scabies
Scabies is a skin disease caused by a tiny mite (Sarcoptes scabiei) that burrows under the skin and is transmitted through close personal contact.3 Scabies and its complications particularly affect
young children especially in topical developing countries.3 The direct effect of scabies is debilitating itching leading to scratching which is in turn followed by complications due to bacterial
infection of the skin ranging from impetigo abscesses and…
