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.: PACTR201411000938131 Date of Approval: 12/11/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of pleural drainage on pulmonary function testing in patients with tuberculous pleural effusions
Official scientific title The effect of pleural drainage on pulmonary function testing in patients with tuberculous pleural effusions
Brief summary describing the background and objectives of the trial Tuberculosis is still a major cause of exudative pleural effusions, and pleural fibrosis and restriction remain well-known complications of tuberculous pleurisy. Current evidence suggests that pleural drainage offers little benefit over and above anti-tuberculous treatment in improving pulmonary function. In 2012/2013 we performed a randomised trial on patients with confirmed tuberculous effusions and performed therapeutic drainage in randomly selected cases. Pulmonary function testing, exercise capacity, chest radiography and ultrasonography were performed at baseline, 7-10 days and at 3 months and compared to a control group.
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 Treatment: Other
Anticipated trial start date 01/10/2012
Actual trial start date 01/10/2012
Anticipated date of last follow up 04/06/2013
Actual Last follow-up date 04/06/2013
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants) 21
Recruitment status Stopped early/ terminated
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation using procedures such as coin-tossing or dice-rolling 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
Experimental Group Pleural complete drainage once at day of admission minutes, until drainage stopped delivering fluid Pleural drainage to dryness of pleural effusion 10 Active-Treatment of Control Group
Control Group Diagnostic tap Once on day of admission minutes until 50ml fluid obtained Pleural tap for diagnostic purposes 11
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Patients with radiological evidence of a pleural effusion (at least 30 % of one hemithorax) 2) At least 2 clinical indicators of active TB which included: (1) known HIV infection (2) persistent cough lasting >3 weeks (3) haemoptysis (4) weight loss >4 kg (5) intermittent fever >3 weeks (6) drenching night sweats >2 weeks 1) age < 18 years 2)former incomplete TB Treatment 3)recent history of invasive procedures within the pleural cavity/recent penetrating chest wall Trauma 4)Incapability to walk 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
Yes 03/10/2012 Stellenbosch University Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
PO Box 19063, Tygerberg Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Difference of restrictive lungfunction parameter FVC (Forced vital capacity) after 3 month compared to baseline day 0 (day of Admission) 7 days later 3 month later
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tygerberg Hospital PO 19063, Tygerberg Cape Town 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Tygerberg Hospital P O Box 19063 Cape Town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hannah Fengels (corresponding author) and all co-authors (Pneumology team at Tygerberg hopspital) P O Box 19063 Cape Town 7505 South Africa Hospital
COLLABORATORS
Name Street address City Postal code Country
Hannah Fengels P O Box 19063 Cape Town 7505 South Africa
Coenraad FN Koegelenberg P O Box 19063 Cape Town 7505 South Africa
Elvis Irusen P O Box 19063 Cape Town 7505 South Africa
Johannes W Bruwer P O Box 19063 Cape Town 7505 South Africa
Elisma Wilken P O Box 19063 Cape Town 7505 South Africa
Enas Batubara P O Box 19063 Cape Town 7505 South Africa
Francois Swart P O Box 19063 Cape Town 7505 South Africa
David Maree P O Box 19063 Cape Town 7505 South Africa
Anndrea Gonnermann Carl-Neuberg-Str. 1 Hannover 30625 Germany
Tobias Welte Carl-Neuberg-Str. 1 Hannover 30625 Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hannah Fengels hannah.fengels@web.de +27219389423 P O Box 19063, Tygerberg
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa post graduate student
Role Name Email Phone Street address
Public Enquiries Coenraad Koegelenberg coeniefn@sun.ac.za +27 21 938 9243 Stellenbosch University & Tygerberg Academic Hospital
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa Associate Professor: Pulmonology
Role Name Email Phone Street address
Scientific Enquiries Coenraad Koegelenberg coeniefn@sun.ac.za +27 21 938 9243 Stellenbosh University & Tygerberg Academic Hospital
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa Associate Professor: Pulmonology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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