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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202301719591790 Date of Registration: 30/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Lung Flute ECO evaluation
Official scientific title Evaluation of the Lung Flute ECO: to assist in sputum production for the detection of tuberculosis
Brief summary describing the background and objectives of the trial Brief background: Many people with pulmonary tuberculosis are unable to produce adequate sputum specimens to facilitate the diagnosis of tuberculosis using rapid molecular diagnostic tests. The Lung Flute ECO is a low-cost, non-invasive, biodegradable device that is designed to assist people to produce sputum. Evidence on the performance of the Lung Flute ECO to assist people to produce sputum for the diagnosis of tuberculosis, in the intended setting of use, is needed to inform future research and policy recommendations. There was a Phase 1 study conducted from February to May 2022 to evaluate whether use of the Lung Flute ECO assists people to produce sufficient sputum for TB testing (>1mL); data collected from participants who took part in the Phase 1 study and who consented to its use for Phase 2 will be included in the analysis of the Phase 2 study. Primary objective: To evaluate whether use of the Lung Flute ECO assists people with presumptive TB to test positive for TB, as compared to video instruction with no device assistance Secondary objectives: To determine the proportion of people who produce sputum (>1mL) after use of the Lung Flute ECO as compared to the proportion of people who produce sputum (>1mL) after video instruction on spontaneous expectoration To evaluate the frequency and severity of adverse device reactions or symptom aggravation reported by people asked to produce sputum after use of the Lung Flute ECO as compared to after video instruction on spontaneous expectoration To compare the financial and economic cost of sputum sample collection and TB diagnosis via LF ECO sputum collection method versus comparator from a health payer’s perspective To assess the cost-effectiveness of LF ECO use for TB diagnosis versus comparator from health payer’s perspective
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 15/07/2022
Actual trial start date 24/08/2022
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 10905
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL N/A
Secondary Ids Issuing authority/Trial register
G2021 114R1 Global Health Innovative Technology - GHIT
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Use of Lung Flute ECO Single-use of Lung Flute ECO for sputum production 20 sets of 2 blows with 10 seconds in between (typically 5-10 minutes) At the visit when the participant is allocated to use the Lung Flute ECO, the device is presented to the participant. The procedure is briefly explained and the participant is provided with a handheld phone or tablet with a 3-minute video demonstration of the usage of the Lung Flute ECO. Then the study personnel asks if the participant has questions and briefly answers any questions asked by the participant. The study personnel then accompanies the participant to the sputum production location and observes from a distance as the participant performs the first set of two blows. If needed, the study personnel provides additional feedback and/or demonstration of the use of the Lung Flute ECO to ensure the participant is using it as advised. The participant then follows along with a real-time video (~6 minutes in length) during the use of Lung Flute ECO. The video is provided in one of four commonly used languages depending on the preference of the participant. 10905
Control Group Video instruction for sputum production Single-time to watch the comparator video for sputum production Typically 3-5 minutes At the visit when the participant is allocated to the comparator method, a short video on how to produce sputum is shown to the participant. The video is ~4 minutes long. The video is provided in one of four commonly used languages depending on the preference of the participant. 10905 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Symptoms suggestive of pulmonary TB and/or an abnormal chest X-ray • Able and willing to provide written informed consent (>20 years) or minor assent (12-20) and parental consent for participants 6-20 years. • Able to understand instructions in one of the four commonly used languages (English, French, Fulfulde, Pidgin) • Contraindicated for sputum induction (Asthma, with acute exacerbation in last two weeks (any attack within the last two weeks); dyspnea or respiratory distress, grade 3 or 4, in the last one week; hypoxemia (SpO2 <90% in ambient air); hemoptysis (coughing up blood), in last one week; history of esophageal operation; known eardrum damage or other middle ear lesions; acute sinusitis, with documentation; nosebleed, in the last one week; nausea, grade 3 or 4, in the last two days; vomiting, grade 3 or 4, in the last two days) • Currently on TB treatment • Inability to sit upright for 20 minutes • Refusal to signed informed consent form or assent form (12-20 years) or parental informed consent form (6-20years). • Other issue raised for exclusion based on the judgement of the clinical and/or study personnel 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 6 Year(s) 105 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 13/07/2022 Institutional Review Board Institute of Tropical Medicine Antwerp
Ethics Committee Address
Street address City Postal code Country
Nationalestraat 155, 2000 Antwerp, Belgium Antwerp 2000 Belgium
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 23/08/2022 National Ethics Committee for Health Research on Human
Ethics Committee Address
Street address City Postal code Country
Hygiene Mobile Yaounde NA Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The estimated proportion of people testing positive for TB Visit 1- Day 0, Visit 2- 2hours to 5 days after visit 1
Secondary Outcome Sputum quantity (<1mL, >1-2mL, >2-3mL, >3-4mL, >4mL) Visit 1- Day 0, Visit 2- 2 hours to 5 days after Visit 1
Secondary Outcome Adverse events or symptom aggravation, with severity grading Visit 1- Day 0, Visit 2- 2hours to 5 days after visit 1
Secondary Outcome Cost per participant tested Cost per TB case diagnosed Summary data- end of study
Secondary Outcome Incremental cost per TB case diagnosed/per participant tested Summary data- end of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bamenda Regional Hospital Hospital round about Bamenda Cameroon
Nkwen Baptist Hospital Finance Junction Bamenda Cameroon
Mboppi Baptist Hospital Mboppi ancien abattoir Douala Cameroon
Bonaberi Baptist Health Center Bonaberi echangeur Douala Cameroon
Mutengene Baptist Hospital Limbe Road Mutengene Cameroon
Meskine Baptist Hospital Meskine Louggol Maroua Cameroon
CMA Founangue Founangue Mbarmare Maroua Cameroon
CSPP Djarengol kodeck Djarengol kodeck Maroua Cameroon
HNDA Djamboutou Djamboutou Garoua Cameroon
Regional Hospital Garoua Kollere Garoua Cameroon
Mbingo Baptist Hospital Mbingo Bamenda Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Global Health Innovative Technology Fund GHIT Ark Hills Sengokuyama Mori Tower 25F, 1-9-10 Roppongi, Roppongi Tokyo 106-0032, JP Tokyo Japan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Research Institute of Tuberculosis RIT 3-1-24 Matsuyama, Kiyose, Tokyo 2048533 JAPAN Tokyo Japan Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Ellen M.H. Mitchell Nationalestraat 155, 2000 Antwerp, Flanders Antwerp Belgium
Ippei Soma 5-8-100 Koyanagicho Fuchu-Shi Toky O 183-0013 Japan Tokyo Japan
Mbuli Cyrille Ndamnsah Hospital Roundabout Bamenda Cameroon
Melissa Sander Hospital Roundabout Bamenda Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Satoshi Mitarai mitarai@jata.or.jp 81424935711 3-1-24 Matsuyama, Kiyose
City Postal code Country Position/Affiliation
Tokyo 2048533 Japan Research Institute of Tuberculosis Japan
Role Name Email Phone Street address
Scientific Enquiries Satoshi Mitarai mitarai@jata.or.jp 12345 3-1-24 Matsuyama, Kiyose
City Postal code Country Position/Affiliation
Tokyo 2048533 Japan Research Institute of Tuberculosis
Role Name Email Phone Street address
Public Enquiries Satoshi Mitarai mitarai@jata.or.jp 81424935711 3-1-24 Matsuyama, Kiyose
City Postal code Country Position/Affiliation
Tokyo 2048533 Japan Research Institute of Tuberculosis
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: Yes Description: Individual participant data collected during the trial, after de-identification Informed Consent Form,Study Protocol Immediately following publication, with no end date Anyone who wishes to access the data for any purpose
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