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.: PACTR201712002829221 Date of Approval: 01/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound in managing Tuberculosis: A randomized controlled two-center study
Official scientific title Ultrasound in managing Tuberculosis: A randomized controlled two-center study
Brief summary describing the background and objectives of the trial Background: In resource-limited settings with high tuberculosis (TB) prevalences, almost half of patients are treated upon clinical suspicion only. Besides challenges in availability of microbiological tests, poor sensitivity of these is a major reason for empiric treatment, especially in patients co-infected with HIV or patients suspected of extrapulmonary TB (EPTB). The consequence is an overtreatment in patients, who might suffer from diseases other than TB. Small studies showed, that Focused Assessment with Sonography for HIV and Tuberculosis (FASH) might be useful to detect signs of EPTB. Moreover, other diseases with similar symptoms as TB can be detected by sonography. Ultrasound might therefore increase the proportion of correctly managed patients (i.e patients who have TB receive anti-TB treatment, whereas patients who do not have TB do not receive anti TB treatment). Objective: To assess the impact of sonography on the proportion of correctly managed patients with suspected EPTB and on morbidity and mortality. Hypothesis: We hypothesize that the proportion of correctly managed patients will be higher in the intervention group receiving sonography than in a standard of care group (81% vs 61%) Design: Randomized controlled not-blinded interventional double-center study Setting: Rural (St Francis Referral Hospital (SFRH), Ifakara, Tanzania) and urban (Mwananyamala Regional Hospital (MRH) in Dar es salaam, Tanzania) Patients: Adults with suspected EPTB. Pregnant women and patients already under anti-TB treatment will be excluded.
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 01/06/2018
Actual trial start date 25/09/2018
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date 31/03/2021
Anticipated target sample size (number of participants) 700
Actual target sample size (number of participants) 701
Recruitment status Completed
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 Stratified allocation (HIV-seropositivity and recruiting center) Patients will be consecutively enrolled and randomized to the intervention group and control group using a web-based randomization program (www.randomizer.org) Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group eFASH extended focussed asessment with sonography for HIV and TB n The intervention consist of the performance of eFASH and a managment algorhithm 350 Active-Treatment of Control Group
Control Group Standard of care n Management according to the desicion of the treating physician 350 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All HIV- positive and HIV- negative patients (adults ¿18 years old) presenting to any department of the St Francis Hospital (SFRH), Ifakara, Tanzania, to the Chronic Disease Clinic of Ifakara (CDCI), or to the Mwananyamala Regional Hospital, Dar es Salaam, Tanzania fulfilling the following criteria for EPTB are eligible: Suspected extrapulmonary EPTB*: presence of ¿ 1 sign or symptom of the following: fever of any duration, night sweat during 3 weeks within the last 4 weeks, weight loss, AND presence of ¿ 1 sign or symptom of the following: nuchal, cervical, axillary or generalized lymphadenopathy, abdominal pain or ascites, neurological symptoms (reduced consciousness, confusion, stiff neck, focal signs, persisting headache), presence of severe anemia (haemoglobin (Hb) < 8 g/dl) in an HIV infected patient under antiretroviral treatment (ART) AND no other obvious explaination for these signs * with or without concommittant signs of pulomonary TB Pregnant women, patients already on TB-treatment, and patients who refuse to participate or lack of written informed consent will not be included. 18 Year(s) 100 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
No 01/02/2018 National Health Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es salaam 11101 Tanzania
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 10/12/2017 Ethikkommission Nordwest und Zentralschweiz EKNZ
Ethics Committee Address
Street address City Postal code Country
Hebelstrasse 53 Basel 4056 Switzerland
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 10/12/2017 Ifakara Health Institute Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Kiko Ave, PO Box 78373 Dar es salaam 11111 Tanzania
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 18/11/2020 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
Barack Obama Drive Dar es salaam 11101 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The proportion of correctly managed patients (i.e A patient who was treated with anti-TB treatment and has definite or probable TB; a patient who has not been treated with anti-TB treatment and has no TB. 6 months
Secondary Outcome The proportion of patients without symptoms 2 and 6 months
Secondary Outcome death 2 and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
St Francis Referral Hospital Ifakara Ifakara Tanzania
Mwananyamala Regional Hospital PO Box 25340 Dar es salaam Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Julia und Gottfried Bangerter Foundation Lange Gasse 15 Basel 4002 Switzerland
Rudolf Geigy Foundation Socinstrasse 57 Basel 4051 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor SwissTPH Socinstrasse 57 Basel 4051 Switzerland Charities/Societies/Foundation
Primary Sponsor Ifakara Health Institute PO Box 53 Ifakara Tanzania Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
University Hospital Basel Petersgraben 4 Basel 4001 Switzerland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Martin Rohacek mrohacek@ihi.or.tz +255625064252 Off Mlabani Passage, PO Box 53
City Postal code Country Position/Affiliation
Ifakara Tanzania Investigator and clinician
Role Name Email Phone Street address
Public Enquiries Honorati Masanja hmasanja@ihi.or.tz +255766520005 Kiko Ave
City Postal code Country Position/Affiliation
Dar es salaam Tanzania Director of IHI
Role Name Email Phone Street address
Scientific Enquiries Daniel Paris daniel.paris@swisstph.ch +41612848111 Socinstrasse 57
City Postal code Country Position/Affiliation
Basel 4051 Switzerland Head of Department of Medicine
REPORTING
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Result URL Hyperlinks
Changes to trial information