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.: PACTR201905466349317 Date of Approval: 15/05/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title THE EFFECT OF ANTIBIOTICS ON POST-ADENOTONSILLECTOMY MORBIDITY IN TANZANIAN CHILDREN
Official scientific title PROPHYLACTIC ROLE OF AMOXICILLIN ON POSTOPERATIVE MORBIDITY AFTER (ADENO)TONSILLECTOMY AMONG CHILDREN IN NORTHERN TANZANIA: A DOUBLE BLIND RANDOMIZED PLACEBO CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Background: Adenotonsillectomy is the most frequently performed operation in children worldwide. For decades prophylactic antibiotics have been prescribed to limit postoperative complications. In a Cochrane review the effect of this antibiotic use has been refuted. However, all reviewed studied were done in developed countries. In Tanzania, like many other developing countries with limited resources and a high burden of infectious diseases, postoperative antibiotic prescription is still very common to decrease the supposed higher postoperative morbidity. However, as a consequence of this widespread use of postoperative antibiotics cross-resistance and risk of allergic side effects rise. Well designed randomised controlled trials are needed to limit unnecessary antibiotic prescription and secondary antibiotic resistance. Aim: The aim of this study is to analyse the prophylactic role of postoperative antibiotic on the morbidity following adenotonsillectomy in children in Tanzania. Design: A double blinded randomised placebo controlled trial set in northern Tanzania. Participating centres are the department of otolaryngology at Kilimanjaro Christian Medical Centre (KCMC) in Moshi and the department of paediatric surgery at the Arusha Lutheran Medical Centre (ALMC) in Arusha. Methods: Around 270 children aged 2 to 14 years, all scheduled for elective (adeno)tonsillectomy, will be included and assigned to receive either a standard regimen of 5 days antibiotic prophylaxis or placebo after surgery. The primary outcomes are postoperative haemorrhage, raised temperature, pain and consequent need for analgesics. Secondary outcomes are the time until normal diet is resumed, the time until normal activities are resumed and the occurrence of adverse events. Finally, microbial recolonization of the tonsillar beds is analyzed. Discussion: This study will enhance increase of proper antimicrobial prescription in Tanzanian institutions as well as other resource-limited countrie
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat,Infections and Infestations,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied Adenotonsillitis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/01/2019
Actual trial start date 18/03/2019
Anticipated date of last follow up 03/03/2020
Actual Last follow-up date 17/03/2020
Anticipated target sample size (number of participants) 270
Actual target sample size (number of participants) 270
Recruitment status Recruiting
Publication URL Not yet
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Amoxicillin 50mg/Kg body weight of Amoxicillin 8 hourly 5 days receiving amoxicillin 50mg/kg body weight eight hourly in the suspension or tablets form for 5 days starting from the day of surgery to fifth day 135 Active-Treatment of Control Group
Experimental Group Placebo 50mg/kg body weight of placebo 8 hourly 5 days receiving placebo 50mg/kg body weight eight hourly in the suspension or tablets form for 5 days starting from the day of surgery to fifth day 135
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All Children from age of 2 and 14 years who will undergo (adeno) tonsillectomy because of recurrent chronic tonsillitis as defined as 5 or more attacks of tonsillitis each year for at least 2 consecutive years or because of obstructive sleep apnea due to adenotonsillar hypertrophy who ave not responded with pharmacotherapy Reported allergy to penicillin, ibuprofen or Paracetamol. Acute tonsillar infection. Undergoing unilateral tonsillectomy, tonsillar biopsy, tonsillectomy for known carcinoma, tonsillectomy in conjunction with palatal surgery and tonsillectomy for peritonsillar abscess. Heart diseases, prosthetic heart valves or any implant in situ. Received antibiotic(s) for the last seven days. Conditions resulting into weakness or failure of the host defense mechanism due to leukemia, acquired immune deficiency syndrome or immunosuppressive treatments. Syndromic children and children with craniofacial malformations. Patients who are using any concomitant medications at the time of enrolment Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 14 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 18/03/2019 Medical Research Coordinating Committee
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive, P.O.Box 9653 Dar es Salaam 11101 United Republic of 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 23/08/2018 Clinical Research Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
2240 Moshi Kilimanjaro 25116 United Republic of 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 27/12/2018 Research Rethics Committee of the Radboud University Nijmegen Medical Centre
Ethics Committee Address
Street address City Postal code Country
Postbus 9101, 6500 HB Nijmegen Huispost 628 Geert Grooteplein 10 Nijmegen 9101 Netherlands
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative haemorrhage 7 and 14 days post operative
Primary Outcome Postoperative pain within 7 days post operative
Secondary Outcome time until normal diet is resumed 7 and 14 days post operative
Secondary Outcome time until normal activities are resumed within 5 days post operative
Secondary Outcome adverse events such as a rash, vomiting, diarrhea and anaphylaxis 7 and 14 days post operative
Secondary Outcome microbial recolonization of the tonsillar beds 14th Day post operative
Primary Outcome Postoperative fever within 7 days post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kilimanjaro Christian Medical Centre Moshi-Longuo B Kilimanjaro 25116 United Republic of Tanzania
Arusha Lutheran Medical Centre Makao Mapya Rd, Arusha Arusha United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Radboud University Medical Centre Revolving Research Fund Postbus 9101, 6500 HB Nijmegen Huispost 383 Philips van Leydenlaan 15 Radboudumc, route 377 Nijmegen 9101 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Training Health Researchers into Vocational Excellence THRiVE Makerere University College of Health Sciences, Kampala Kampala Uganda Charities/Societies/Foundation
Secondary Sponsor Tanzania Ministry of Health Community Development Gender Elderly and Children MoHCDEC University of Dodoma, College of Social Science and Humanity, Block 11, P.O. Box 573, 40478 Dodoma 00255 Tanzania Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Radboud University Medical Centre Department of Otorhinolaryngology Postbus 9101, 6500 HB Nijmegen Huispost 383 Philips van Leydenlaan 15 Radboudumc, route 377 Nijmegen Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Denis Robert Katundu katundu101@gmail.com +255713828862 3310 KCMC
City Postal code Country Position/Affiliation
Kilimanjaro United Republic of Tanzania Resident Doctor
Role Name Email Phone Street address
Scientific Enquiries Niels Van Heerbeek Niels.vanHeerbeek@radboudumc.nl +3161675651 Postbus 9101, 6500 HB Nijmegen Huispost 383 Philips van Leydenlaan 15 Radboudumc, route 377
City Postal code Country Position/Affiliation
Nijmegen United Republic of Tanzania Promoter
Role Name Email Phone Street address
Public Enquiries Denis Robert Katundu katundu101@gmail.com +255713828862 3310
City Postal code Country Position/Affiliation
Kilimanjaro United Republic of Tanzania Resident Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data results will be shard once analysis is done and the data are available Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol January 2021 General Public
URL Results Available Results Summary Result Posting Date First Journal Publication Date
will be shared as it will be available 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