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.: PACTR202210778524094 Date of Approval: 13/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Doxycycline Plus Trimethoprim-sulfamethoxazole Versus Doxycycline Plus Rifampicin in Treatment of Brucellosis
Official scientific title Doxycycline Plus Trimethoprim-sulfamethoxazole Versus Doxycycline Plus Rifampicin in Treatment of Brucellosis
Brief summary describing the background and objectives of the trial There are multiple drug combinations that are used in brucellosis treatment. The combination of doxycycline plus rifampicin for 6 weeks is the most used regimen. Doxycycline with Trimethoprim-sulfamethoxazole is another suggested regimen. We herein aim to compare the efficacy of two drug regimens used for treatment of brucellosis (Doxycycline Plus Trimethoprim-sulfamethoxazole Versus Doxycycline Plus Rifampicin) in Egyptian patients
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 Brucellosis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/09/2022
Actual trial start date
Anticipated date of last follow up 30/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
17300850
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Doxycycline plus Trimethoprim sulfamethoxazole Doxycycline (100 mg twice a day), Trimethoprim-sulfamethoxazole (160 mg of trimethoprim plus 800 mg of sulfamethoxazole twice a day) Six weeks Oral drug combination for six weeks 50
Experimental Group Doxycycline plus Rifampicin Doxycycline (100 mg twice a day) Rifampicin (600 mg per day) Six weeks Oral Drugs 50
Control Group NO No NO NO 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
consecutive 100 patients with brucellosis who attend our outpatient clinic and inpatient ward will be enrolled in our study. Complicated localized brucellosis (spondylitis, endocarditis, meningoencephalitis). Age less than 18 years Pregnancy Receiving antibiotics for more than 1 week before enrolment 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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 10/10/2022 Assiut Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Assiut university - Faculty of Medicine Assiut 71515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Successful Treatment At the end of treatment
Primary Outcome Failure of therapy At the end of treatment
Primary Outcome Relapse Within 6 months of the end of treatment
Secondary Outcome Stoppage of treatment At any time if side effects occured that necessiate stopagge of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alrajhy University Hospital Assiut university Hospitals - Al-rajhi university hospital Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Assiut University Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Assiut University Hospital Assiut University Hospital - Al-rajhi hospital Assiut Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Waleed Attia Hassan wallo403a@aun.edu.eg 00201554544895 Assiut university - Fever department
City Postal code Country Position/Affiliation
Assiut Egypt Lecturer of Tropical Medicine and Gastroenterology
Role Name Email Phone Street address
Scientific Enquiries Ahmed Shawkat Shawkatahmed84@aun.edu.eg 00201028030699 Assiut University - Al-rajhi hospital
City Postal code Country Position/Affiliation
Assiut Egypt Lecturer of Tropical Medicine and Gastroenterology
Role Name Email Phone Street address
Public Enquiries Mohammed Abdel Mawgood Muhammad2013@azhar.edu.eg 00201113528652 Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Assistant Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Sharing of data will be within 1 year Open access
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