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Pediatric Antibiotic Associated Diarrhea (TURPENADA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03265730
Recruitment Status : Unknown
Verified November 2017 by Ates Kara, Hacettepe University.
Recruitment status was:  Recruiting
First Posted : August 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Ates Kara, Hacettepe University

Brief Summary:
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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence, Risk Factors and Severity of Pediatric Antibiotic Associated Diarrhea
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea




Primary Outcome Measures :
  1. Incidence of Antibiotic Associated Diarrhea (AAD) in Children in Turkey [ Time Frame: December 2018 ]
    How common the antibiotic associated diarrhea is encountered in pediatric age group in outpatient clinic in Turkey.


Secondary Outcome Measures :
  1. Local differences in pediatric AAD across Turkey [ Time Frame: December 2018 ]

    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.


  2. Follow-up of Severity of AAD in Outpatient Clinics and by Phone Calls for Two Months Period in Pediatric Population in Turkey. [ Time Frame: December 2018 ]

    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.


  3. Incidence of antibiotic associated diarrhea with different type and formulation of antibiotic [ Time Frame: December 2018 ]
    Incidence of antibiotic associated diarrhea with different class of antibiotics will be determined

  4. Incidence of antibiotic associated diarrhea in different age groups [ Time Frame: December 2018 ]
    Differences in incidence and severity of AAD in children with different age groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265730


Contacts
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Contact: Sevgen Tanır Basaranoglu, MD + 90 532 7498624 sevgent@gmail.com
Contact: Ates Kara, Professor +90 532 4135130 ateskara@me.com

Locations
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Turkey
Hacettepe University Recruiting
Ankara, Turkey, 06100
Contact: Sevgen Tanır Basaranoglu, MD    +90 532 7498624    sevgent@gmail.com   
Contact: Ates Kara, Professor    + 90 532 4135130    ateskara@me.com   
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Ates Kara, Professor Hacettepe University
Publications:
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Responsible Party: Ates Kara, Prof Dr, Hacettepe University
ClinicalTrials.gov Identifier: NCT03265730    
Other Study ID Numbers: Hacettepe01
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ates Kara, Hacettepe University:
Outpatient clinics
oral antibiotics
diarrhea
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms