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.: PACTR201508001234317 Date of Approval: 11/08/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Sodium Bicarbonate 8.4% Inhalation on Smear Positive Tuberculosis
Official scientific title Effect of Sodium Bicarbonate 8.4% Inhalation on Smear Positive Tuberculosis
Brief summary describing the background and objectives of the trial Mycobacterium tuberculosis is exposed to a variety of acidic conditions within the human body. These can include the classical location within the phagosome of an alveolar macrophage. It may also include the centers of caseating granulomas which can be quite acidic as has been found to be true in a rabbit model of tuberculosis. Change the acidic medium may affect the growth of the bacilli and affect its response to antituberculous treatment and may improve the radiological as well as the clinical response to treatment.The aim of this work is to assess the effect of the alkalinization of the airway surface fluid using a fluid usually used in clinical practice (sodium bicarbonate 8.4%) on the growth and multiplication of the TB bacilli in the respiratory tract; as detected by positivity of the sputum for acid fast bacilli on staining with Zeihl Neelsen (ZN), TB culture on Lowenstein Jensen medium, on the clinical and radiological course of TB.
Type of trial CCT
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 01/03/2015
Actual trial start date 21/05/2015
Anticipated date of last follow up 30/06/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 65
Actual target sample size (number of participants)
Recruitment status 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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group study group A full regimen of anti TB drugs in addition to inhalation of sodium bicarbonate 8.4% in a dose of 5 ml every 6 hours until the conversion of smear into negativity 30
Control Group Control group B full regimen of anti TB drugs alone standard duration 15 Active-Treatment of Control Group
Experimental Group Study group C (MDR-TB) receive the recommended regimen according to drug sensitivity in addition to inhalation of sodium bicarbonate 8.4% in a dose of 5 ml/ 6 hours until the conversion of smear into negativity 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patient with active pulmonary TB who accept to participate in the study 1. Sputum negative TB. 2. Extrapulmonary only tuberculous patient. 3. Patients refusing to share in the study. 18 Year(s) 70 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 01/08/2015 MMREC
Ethics Committee Address
Street address City Postal code Country
Elgomhoria Mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Sputum ZN stain every week till sputum conversion to negative then at the end of the recommended anti-TB regimen.
Primary Outcome TB culture on Lowenstein Jensen medium at the start of the study, and then monthly
Secondary Outcome Radiologic Chest X ¿ ray (PA) to assess presence of associated TB complications or incidental lesion/ 2 weeks. CT chest: at the start of the study, at the time of sputum conversion to negative then every month
Secondary Outcome Safety of the procedure during the course of inhalation of SB
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
chest department Elgomhoria Mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding source
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor chest department, mansoura faculty of medicine Elgomhoria Mansoura 35511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammad Khairy El Badrawy Haielgamaa Mansoura 35511 Egypt
Eman Omar Arram Saad Zaghlol sinbillawin 35511 Egypt
Alaa El Din Hussien Zahran Teraa Mansoura 35511 Egypt
Dina Ahmad Mohammad El-Sagheer Teraa Mansoura 35511 Egypt
Dina Abouelkheir AbdAlla Toril Mansoura 35511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammad khairy El-Badrawy profkhairy2008@yahoo.com +2 01114725911 Haielgamaa
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Professor of chest medicine Faculty of medicine, Mansoura University
Role Name Email Phone Street address
Public Enquiries Dina Abouelkheir AbdAlla dkhair@mans.edu.eg +2 01009976012 Toril
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of chest medicine Faculty of medicine, Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Dina Abouelkheir AbdAlla dkhair@mans.edu.eg +2 01009976012 Toril
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of chest medicine Faculty of medicine, Mansoura University
REPORTING
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