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: www.pactr.org
Trial no.: PACTR201905784271304 Date of Approval: 15/05/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Fast and reliable easy-to-use-diagnostics for eliminating Bilharzia in young children and mothers (freeBILy)
Official scientific title Fast and reliable easy-to-use-diagnostics for eliminating Bilharzia in young children and mothers (freeBILy)
Brief summary describing the background and objectives of the trial freeBILy is a Cluster Randomized controlled trial of the “Test based Schistosomiasis Treatment (TBST)” public health intervention implemented in 20 intervention study centres and compared to 20 non-intervention study centres, plus 2 nonrandomized training centres. The target population are Pregnant women and children born from enrolled mothers with an estimated sample size of 5200 tandems. The trial will be conducted in 42 sites spread over two main regions of Madagascar: Antananarivo and Fianarantsoa. Following enrolment during pregnancy the women will be seen at 4 follow-up visits at 8 months of pregnancy, at delivery, at 9 and 24 months after delivery. The children will be seen at 2 follow-up visits at 9 and 24 months of age. The enrolment phase is expected to take 6 months, Study Purpose: To integrate Test based Schistosomiasis Treatment (TBST) into routine mother child Primary health care programmes in order to demonstrate its usefulness for controlling schistosomiasis in young children and mothers. Study Objectives are: - To compare schistosomiasis-morbidity associated growth and developmental disadvantages in young children and schistosomiasis-morbidity associated anaemia disadvantages in mothers in TBST to non-TBST sites. - To evaluate the sensitivity and specificity of the POC-CCA test with urine in routine mother child primary health care programmes for the detection of Schistosoma mansonii infections. Study endpoints are: The outcome measured to assess the impact of (TBST) on child growth will be height for age at 2 years. The outcome measured to assess the impact of (TBST) on mothers will be maternal haemoglobin (Hb).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) freeBILy
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Schistosomiasis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/12/2018
Actual trial start date 04/04/2019
Anticipated date of last follow up 04/07/2021
Actual Last follow-up date 04/09/2021
Anticipated target sample size (number of participants) 5200
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Praziquantel 40mg/kg following diagnosis One dose Pregnant women and newborns are not diagnosed via the use of a rapid diagnostic test so they will be treated with praziquantel according to the national guidelines which currently don't include treatment for children under 5 years and it includes the treatment for pregnant women just in case of a certain diagnosis. The diagnosis cannot be done at the PHCC so the treatment, if given, will not be performed on the same day of the consultation. 2600 Uncontrolled
Experimental Group Praziquantel 40 mg/kg after diagnosis one dose Pregnant women and newborns are diagnosed via the use of a rapid diagnostic test and treated with praziquantel if positive for the infection 2600
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Informed consent signed (from the parents for minors) - Expected residency in the area of the study site for the next 24 months - Pregnant women between their 5th and 6th months of pregnancy - Children born from an enrolled mother, including twins - Willingness to comply with the protocol requirements including: sampling and treatment for both mothers and children - Fever (temporary exclusion) - History of transfusion - History of congenital anaemia - Epileptic or convulsive episodes - Non-pregnant women - Pregnant women younger than 16 years old - Pregnant women who have not completed their 4th month of pregnancy - Pregnant women over their 6th month of pregnancy - Pregnant women who do not live in the area of the CSB - Children born from mothers not enrolled in the study - Children born in a CSB different from the ones in which the mothers were enrolled Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 0 Day(s) 60 Year(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
Yes 18/03/2019 Arztekammer Hamburg
Ethics Committee Address
Street address City Postal code Country
Weidestarsse 122b Hamburg 22083 Germany
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/03/2018 Comite d ethique de la recherche biomedicale
Ethics Committee Address
Street address City Postal code Country
BP 873 Antananarivo 1014768 Madagascar
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Height for age at 24 months will be used to measure the impact of TBST. Weight and height of children will be measured at birth, at 9 months and 24 months of age. T2, T3, T4
Primary Outcome Maternal Hb at 24 months after delivery will be used to measure the impact of TBST. Maternal Hb will be measured at enrolment before delivery (8th month of pregnancy), 9 months after delivery and at two years after delivery. T0, T1, T3, T4
Secondary Outcome Sensitivity and specificity of the POC-CCA test compared to the panel reference standard (measured in the cross-sectional study at Imerentsiatosika and Andina). T0
Secondary Outcome Prevalence of S. mansoni and S. haematobium in pregnant women and U5 children T0, T1, T2, T3, T4
Secondary Outcome Women’s quality of life related to health (measured by EQ-5D tool) and capacity to work and earn in routine activities T0, T1, T3, T4
Secondary Outcome Costs of the interventions T4
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UT University of Antananarivo BP 4299- Ankatso Antananarivo 101242655 Madagascar
UF University of Fianarantsoa 7 Amboistra Amboistra Madagascar
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Anna van Saksenlaan 51 The Hague 2593 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bernhard Nocht Institute of Tropical Medicine Bernhard Nocht Strasse 74 Hamburg 20359 Germany Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Leiden University Medical Center Albinusdreef 2 Leiden Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Norbert Schwarz schwarznorbert@bni-hamburg.de +494042818503 Bernhard Nocht Strasse 74
City Postal code Country Position/Affiliation
Hamburg 20359 Germany Group leader BNITM
Role Name Email Phone Street address
Scientific Enquiries Daniela Fusco fusco@bnitm.de +494042818503 Bernhard Nocht Strasse 74
City Postal code Country Position/Affiliation
Hamburg Germany Post doc BNITM
Role Name Email Phone Street address
Principal Investigator Raphael Rakotozandrindrainy rakrapha13@gmail.com 00261320210812 BP 4299
City Postal code Country Position/Affiliation
Antananarivo Madagascar Professor University of Antananarivo
Role Name Email Phone Street address
Public Enquiries Daniela Fusco fusco@bnitm.de +494042818243 Bernhard Nocht Strasse, 74
City Postal code Country Position/Affiliation
Hamburg Germany Senior postdoc BNITM
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual participant data be available (including data dictionaries)? --> yes What data in particular will be shared? --> all of the individual participant data collected during the trial, after anonymization Each participant included into the study receives a unique identifier, babies will receive a different identifier that is connected to the one of their mothers. The format of the Study ID will be the following: - F18-X0001-XX o F18 = study abbreviation o X = 1 for mothers, 2 for children, 3 for twin o 0001 – 5200 = sequential enrolled participants o X = T for Antananarivo (Tana), F for Fianarantsoa o X = A to U for the different sites The identity of the participant is kept on site Data is recorded on paper-based case report forms (CRF) and then digitalized using the REDCap software system. Demographic, anthropometric and clinical data will be transcribed directly into the CRF. Haemoglobin (Hb) will be measured using the “HemoCue” system, which consists of a handheld device to measure Hb in a drop of blood soaked into a strip. Hb measurement results will be registered in the CRF. Rapid test results without a reader (as in the HemoCue) system such as the POC-CCA are judged by a trained study nurse and the result written into the CRF. Informed Consent Form,Statistical Analysis Plan,Study Protocol When will data be available (start and end dates)? --> Immediately following the publication and no end date is cosnidered for sharing. Both the hard version (paper CRF) and electronic version of the study data is archived. Study documents and participants folder are archived at University of Antananarivo, University of Fianarantsoa and CICM according to the institutional SOPs for at least 10 years. They are kept in a temperature and humidity controlled environment with protection against theft and pests. Electronic archiving of study data is based on a study specific standard operating procedure. With whom? --> Data can be shared with partner institutions after request to and confirmation of the PI. For external requests, the Scientific Review Committee and the PI decide, based on information such as the study protocol. For what type of analyses? --> any purposes covered by the informed consent By what mechanism will data be made available? --> data are stored at BNITM in the protected owncloud server. To gain access to the data request should go via email to the sponsor and the data manager. Contact email will be provided at the end of the study Access to the REDCap database of freeBILy-MAD study will be granted to freeBILy-MAD study team for quality control purposes. Data may be shared with other sites at the request of the freeBILy steering committee. Data can be shared with partner institutions after request to and confirmation of the PI. For external requests, the Scientific Review Committee and the PI decide, based on information such as the study protocol. REDCap allows the export into several commonly used data formats, including csv.
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
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 15/04/2019 upon request of the board Undecided Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 15/04/2019 the plan was already existing, the coordination team was not sure about the mandatory requirement for that Each participant included into the study receives a unique identifier, babies will receive a different identifier that is connected to the one of their mothers. The format of the Study ID will be the following: - F18-X0001-XX o F18 = study abbreviation o X = 1 for mothers, 2 for children, 3 for twin o 0001 – 5200 = sequential enrolled participants o X = T for Antananarivo (Tana), F for Fianarantsoa o X = A to U for the different sites The identity of the participant is kept on site Data is recorded on paper-based case report forms (CRF) and then digitalized using the REDCap software system. Demographic, anthropometric and clinical data will be transcribed directly into the CRF. Haemoglobin (Hb) will be measured using the “HemoCue” system, which consists of a handheld device to measure Hb in a drop of blood soaked into a strip. Hb measurement results will be registered in the CRF. Rapid test results without a reader (as in the HemoCue) system such as the POC-CCA are judged by a trained study nurse and the result written into the CRF.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 15/04/2019 the plan was already existing, the coordination team was not sure about the mandatory requirement for that Both the hard version (paper CRF) and electronic version of the study data is archived. Study documents and participants folder are archived at University of Antananarivo, University of Fianarantsoa and CICM according to the institutional SOPs for at least 10 years. They are kept in a temperature and humidity controlled environment with protection against theft and pests. Electronic archiving of study data is based on a study specific standard operating procedure.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 15/04/2019 the plan was already existing, the coordination team was not sure about the mandatory requirement for that Access to the REDCap database of freeBILy-MAD study will be granted to freeBILy-MAD study team for quality control purposes. Data may be shared with other sites at the request of the freeBILy steering committee. Data can be shared with partner institutions after request to and confirmation of the PI. For external requests, the Scientific Review Committee and the PI decide, based on information such as the study protocol. REDCap allows the export into several commonly used data formats, including csv.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 15/04/2019 the plan was already existing, the coordination team was not sure about the mandatory requirement for that Study Protocol, Statistical Analysis Plan, Informed Consent Form
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 16/04/2019 In response to reviewer request Control Group, Praziquantel, 40mg/kg following diagnosis , One dose , Pregnant women and newborns are not diagnosed via the use of a rapid diagnostic test so they will be treated with praziquantel according to the national guidelines which currently don't include treatment for children under 5 years and it includes the treatment for pregnant women just in case of a certain diagnosis. The diagnosis cannot be done at the PHCC so the treatment, if given, will not be performed on the same day of the consultation., 2600, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 25/04/2019 Reviewers request Each participant included into the study receives a unique identifier, babies will receive a different identifier that is connected to the one of their mothers. The format of the Study ID will be the following: - F18-X0001-XX o F18 = study abbreviation o X = 1 for mothers, 2 for children, 3 for twin o 0001 – 5200 = sequential enrolled participants o X = T for Antananarivo (Tana), F for Fianarantsoa o X = A to U for the different sites The identity of the participant is kept on site Data is recorded on paper-based case report forms (CRF) and then digitalized using the REDCap software system. Demographic, anthropometric and clinical data will be transcribed directly into the CRF. Haemoglobin (Hb) will be measured using the “HemoCue” system, which consists of a handheld device to measure Hb in a drop of blood soaked into a strip. Hb measurement results will be registered in the CRF. Rapid test results without a reader (as in the HemoCue) system such as the POC-CCA are judged by a trained study nurse and the result written into the CRF. Will individual participant data be available (including data dictionaries)? --> yes What data in particular will be shared? --> all of the individual participant data collected during the trial, after anonymization Each participant included into the study receives a unique identifier, babies will receive a different identifier that is connected to the one of their mothers. The format of the Study ID will be the following: - F18-X0001-XX o F18 = study abbreviation o X = 1 for mothers, 2 for children, 3 for twin o 0001 – 5200 = sequential enrolled participants o X = T for Antananarivo (Tana), F for Fianarantsoa o X = A to U for the different sites The identity of the participant is kept on site Data is recorded on paper-based case report forms (CRF) and then digitalized using the REDCap software system. Demographic, anthropometric and clinical data will be transcribed directly into the CRF. Haemoglobin (Hb) will be measured using the “HemoCue” system, which consists of a handheld device to measure Hb in a drop of blood soaked into a strip. Hb measurement results will be registered in the CRF. Rapid test results without a reader (as in the HemoCue) system such as the POC-CCA are judged by a trained study nurse and the result written into the CRF.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 25/04/2019 Reviewers request Both the hard version (paper CRF) and electronic version of the study data is archived. Study documents and participants folder are archived at University of Antananarivo, University of Fianarantsoa and CICM according to the institutional SOPs for at least 10 years. They are kept in a temperature and humidity controlled environment with protection against theft and pests. Electronic archiving of study data is based on a study specific standard operating procedure. When will data be available (start and end dates)? --> Immediately following the publication and no end date is cosnidered for sharing. Both the hard version (paper CRF) and electronic version of the study data is archived. Study documents and participants folder are archived at University of Antananarivo, University of Fianarantsoa and CICM according to the institutional SOPs for at least 10 years. They are kept in a temperature and humidity controlled environment with protection against theft and pests. Electronic archiving of study data is based on a study specific standard operating procedure.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 25/04/2019 Reviewers request Access to the REDCap database of freeBILy-MAD study will be granted to freeBILy-MAD study team for quality control purposes. Data may be shared with other sites at the request of the freeBILy steering committee. Data can be shared with partner institutions after request to and confirmation of the PI. For external requests, the Scientific Review Committee and the PI decide, based on information such as the study protocol. REDCap allows the export into several commonly used data formats, including csv. With whom? --> Data can be shared with partner institutions after request to and confirmation of the PI. For external requests, the Scientific Review Committee and the PI decide, based on information such as the study protocol. For what type of analyses? --> any purposes covered by the informed consent By what mechanism will data be made available? --> data are stored at BNITM in the protected owncloud server. To gain access to the data request should go via email to the sponsor and the data manager. Contact email will be provided at the end of the study Access to the REDCap database of freeBILy-MAD study will be granted to freeBILy-MAD study team for quality control purposes. Data may be shared with other sites at the request of the freeBILy steering committee. Data can be shared with partner institutions after request to and confirmation of the PI. For external requests, the Scientific Review Committee and the PI decide, based on information such as the study protocol. REDCap allows the export into several commonly used data formats, including csv.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 15/05/2019 Correction to include all ages specified Infant: 0 Month-23 Month, Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) Infant: 0 Month-23 Month, Preschool Child: 2 Year-5 Year, Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 07/02/2020 Recruitment completed on the 5th of February 2020. 5203 women are part of the study Recruiting Closed to recruitment,follow-up continuing