Pediatric Antibiotic Associated Diarrhea (TURPENADA)

Incidence, Risk Factors and Severity of Pediatric Antibiotic Associated Diarrhea

Diarrhea is one of the side effects of antibiotics. Antibiotic associated diarrhea can be encountered between two hours to two months after starting of antibiotics. The purpose of the study is to determine incidence,risk factors and severity of pediatric antibiotic associated diarrhea in Turkey.

Study Overview

• Status: Unknown
• Conditions: Diarrhea

Detailed Description

Antibiotic associated diarrhea is a common adverse effect, occurring about 5-30% of patients either early during treatment or up to two months after the cessation of the treatment. The frequency differs according to the definition of diarrhea, the inciting antimicrobial agent and the host factors such geriatric age, immunosuppression, prolonged hospitalization. Almost all agents, especially the the ones acting on anaerobes may cause diarrhea. Clinical presentations range from mild diarrhea to fulminant pseudomembranous enterocolitis. In Turkey still data about antibiotic associated diarrhea is not enough. Incidence and the factors that effect severity are not known.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Sevgen Tanır Basaranoglu, MD; Phone Number: + 90 532 7498624; Email: sevgent@gmail.com
• Study Contact Backup: Name: Ates Kara, Professor; Phone Number: +90 532 4135130; Email: ateskara@me.com

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Recruiting
    • Hacettepe University
    • Contact: Sevgen Tanır Basaranoglu, MD; Phone Number: +90 532 7498624; Email: sevgent@gmail.com
    • Contact: Ates Kara, Professor; Phone Number: + 90 532 4135130; Email: ateskara@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children who admit to outpatient clinics and are ordered oral antibiotics for acute infections such as upper and lower respiratory tract infections, infections of mouth, urinary tract infections, skin and soft tissue infections.

Description

Inclusion Criteria:

• The parents and the child who give consent
• The children who are treated for the acute infections in the outpatient clinics and whole treatment is completed in the outpatient clinics.
• Children who are born mature, for the children who are younger than 1 year of age.

Exclusion Criteria:

• The parents and child who do not give consent
• Children who have primary and secondary immunosuppressive states.
• Children who had abdominal/gastrointestinal tract surgery in the past.
• Children who had used probiotics/prebiotics in the last one month period.
• Children who had used antibiotics in the last one month period.
• Children who has accompanying gastrointestinal symptoms.
• Children who are using anti-acid treatment at the time of involvement.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Antibiotic Associated Diarrhea (AAD) in Children in Turkey	How common the antibiotic associated diarrhea is encountered in pediatric age group in outpatient clinic in Turkey.	December 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local differences in pediatric AAD across Turkey	Differences in incidence and severity of AAD in children in different cities in Turkey. The incidence of antibiotic associated diarrhea will be expressed as proportion of new cases of diarrhea to total number of patients in the follow-up period of patients who receive oral antibiotics. The overall ratio will be calculated at the end of whole study period.	December 2018
Follow-up of Severity of AAD in Outpatient Clinics and by Phone Calls for Two Months Period in Pediatric Population in Turkey.	Duration of AAD and interventional requirements of pediatric patients who develop AAD. Development of diarrhea during study period will be determined by using Bristol Stool Charts. Stool charts will be provided to parents by the investigators. The parents will follow number and shape and consistency of stool , and decide according to the Bristol Stool Chart. Four times and more defecation and stool in type 5,6 and 7 according to Bristol Chart that will continue for a minimum of 2 days will be regarded as diarrhea. If the diarrhea necessitates hospitalization and/or intravenous hydration therapy, this will be regarded as severe diarrhea. If patient with diarrhea will treated by just observation and diarrhea will subside spontaneously, diarrhea will be regarded as mild.	December 2018
Incidence of antibiotic associated diarrhea with different type and formulation of antibiotic	Incidence of antibiotic associated diarrhea with different class of antibiotics will be determined	December 2018
Incidence of antibiotic associated diarrhea in different age groups	Differences in incidence and severity of AAD in children with different age groups.	December 2018

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Ates Kara, Professor, Hacettepe University

Publications and helpful links

General Publications

• Barbut F, Meynard JL. Managing antibiotic associated diarrhoea. BMJ. 2002 Jun 8;324(7350):1345-6. doi: 10.1136/bmj.324.7350.1345. No abstract available.
• Szajewska H, Canani RB, Guarino A, Hojsak I, Indrio F, Kolacek S, Orel R, Shamir R, Vandenplas Y, van Goudoever JB, Weizman Z; ESPGHAN Working Group for ProbioticsPrebiotics. Probiotics for the Prevention of Antibiotic-Associated Diarrhea in Children. J Pediatr Gastroenterol Nutr. 2016 Mar;62(3):495-506. doi: 10.1097/MPG.0000000000001081.
• Wistrom J, Norrby SR, Myhre EB, Eriksson S, Granstrom G, Lagergren L, Englund G, Nord CE, Svenungsson B. Frequency of antibiotic-associated diarrhoea in 2462 antibiotic-treated hospitalized patients: a prospective study. J Antimicrob Chemother. 2001 Jan;47(1):43-50. doi: 10.1093/jac/47.1.43.
• Lau CS, Chamberlain RS. Probiotics are effective at preventing Clostridium difficile-associated diarrhea: a systematic review and meta-analysis. Int J Gen Med. 2016 Feb 22;9:27-37. doi: 10.2147/IJGM.S98280. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: August 26, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: diarrhea; oral antibiotics; Outpatient clinics
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: Hacettepe01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No