Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202004540256535 Date of Approval: 14/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ICARIA (Improving Care through Azithromycin Research for Infants in Africa)
Official scientific title Evaluation of the Impact on Childhood Mortality of Azithromycin Plus Intermittent Preventive Treatment Administered Through the Expanded Program on Immunization in Sierra Leone
Brief summary describing the background and objectives of the trial To provide the evidence needed to inform policy and practice and to accelerate the implementation of this intervention, a large-scale clinical trial on the impact on all-cause mortality up to 18 months of age of azithromycin (AZi) administration through the World Health Organisation (WHO) Expanded Program on Immunisation (EPI) will be carried out in Sierra Leone. The clinical trial will be individually randomised, placebo-controlled with a factorial design whereby AZi will be administered alongside routine preventive health interventions of the EPI, such as immunisations and Intermittent Preventive Treatment in infants (IPTi), which is recommended by the WHO for malaria prevention in this age group. The potential development of antibiotic resistance, the interactions with routine immunisations, the safety and the impact on the health system of AZi administration will be all assessed in this trial.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ICARIA
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics,Respiratory
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Prevention
Anticipated trial start date 01/12/2020
Actual trial start date
Anticipated date of last follow up 01/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 20560
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1 20mg/kg of weight, for 3 doses. 15 months AZi at Penta-1 visit, IPTi-SP at Penta-2 and Penta-3 visits, AZi plus IPTi-SP at measles visit at 9 months of age and placebo-placebo at measles visit at 15 months of age 10280
Control Group Group 2 20mg/kg by weight, for 3 doses. 15 months AZi at Penta-1 visit, IPTi-SP at Penta-2 and Penta-3 visits, AZi plus IPTi-SP at measles visit at 9 months of age and placebo-placebo at measles visit at 15 months of age 10280 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Parents/guardians have signed the informed consent • Permanent residence in the study area-health facility catchment area • Without known allergies to or contraindications to macrolides • Without known allergies to or contraindications to SP • Agreement to complete the EPI scheme at the recruitment health facility • Parents/guardians agree to participate • Residence outside the study area or planning to move out in the following 12 months from enrolment • Known history of allergy or contraindications to macrolides and/or SP • Known history of allergy or contraindications to SP • With signs of any acute illness at the time of recruitment • Participating in other intervention studies Infant: 0 Month(s)-12 Month(s) 6 Week(s) 8 Week(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 24/01/2020 CElm Hospital Clinic de Barcelona
Ethics Committee Address
Street address City Postal code Country
Calle Rossello, 138 baixos, despatx 12 Barcelona 08036 Sierra Leone
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 07/02/2020 Sierra Leone Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
Youyi Building, Fifth Floor, East Wing Freetown 47235 Sierra Leone
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome All-cause mortality 18 months of age
Secondary Outcome The cause-specific mortality rate 18 months of age
Secondary Outcome Malaria-related mortality 18 months of age
Secondary Outcome Incidence of all-cause hospital admissions Longitudinal
Secondary Outcome Incidence of all-cause outpatient attendances Longitudinal
Secondary Outcome Incidence of confirmed (RDT positive) malaria outpatient attendances Longitudinal
Secondary Outcome Incidence of confirmed (blood smear positive) malaria hospital admissions Longitudinal
Secondary Outcome Frequency and severity of drug adverse reactions Longitudinal
Secondary Outcome Prevalence of SP resistance in U5 children Longitudinal
Secondary Outcome Prevalence of macrolide resistance in nasopharyngeal isolates Longitudinal
Secondary Outcome Prevalence of macrolide resistance in the gut bacteria Longitudinal
Secondary Outcome The proportion of children with protective antibody responses to specific routine EPI immunisations (measles and yellow fever) Longitudinal
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lungi Under Five Clinic Port Loko Port Loko Sierra Leone
Lunsar CHC Lunsar Lunsar Sierra Leone
Port Loko Under Five Clinic Port Loko Port Loko Sierra Leone
Mahera CHC Port Loko Port Loko Sierra Leone
Masiaka CHC Koya Koya Sierra Leone
Rogbere CHC Rogbere Rogbere Sierra Leone
Magburaka Under Five Clinic Magburaka Magburaka Sierra Leone
Masingbi CHC Masingbi Tonkolili Sierra Leone
Red Cross Clinic Bombali Sebora Bombali Sierra Leone
Loreto Clinic Loreto Bombali Sierra Leone
Mange CHC HF Port Loko Port Loko Sierra Leone
Matotoka CHC Tonkolili Tonkolili Sierra Leone
Stocco CHP Bombali Bombali Sierra Leone
Binkolo CHC Bombali Bombali Sierra Leone
Makama CHP Bombali Bombali Sierra Leone
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 500 5th Ave N Seattle 98109 United States of America
La Caixa Banking Foundation C. de Napols, 257 Barcelona 08025 Spain
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Barcelona Institute for Global Health Calle Rosello 132 Barcelona Spain Private Research Foundation
COLLABORATORS
Name Street address City Postal code Country
Colleage of Medicine and Allied Health Science University of Sierra Leone Freetown Sierra Leone
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Clara Menendez clara.menendez@isglobal.org 932275400 Calle rosello 132. 5th
City Postal code Country Position/Affiliation
barcelona Spain ISGlobal
Role Name Email Phone Street address
Public Enquiries Anna Lucas anna.lucas@isglobal.org +34676658752 Carrer Rosello 132, 7th floor
City Postal code Country Position/Affiliation
Barcelona 08036 Spain Project Manager
Role Name Email Phone Street address
Scientific Enquiries Mireia Llach mireia.llach@isglobal.org +34932275400 Carrer Rosello 132, 5-1
City Postal code Country Position/Affiliation
Barcelona 08036 Spain Senior Epidemiologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The IPD would be submitted in forms of study report after study closure. Clinical Study Report,Study Protocol Within two years of the study closure. Controlled.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information