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The effect of IV antibiotics on gut flora during an episode of fever in children with cancer.


- candidate number24120
- NTR NumberNTR5806
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-mrt-2016
- Secondary IDsM15.174103 Medische Ethische Toetsingscommissie
- Public TitleThe effect of IV antibiotics on gut flora during an episode of fever in children with cancer.
- Scientific TitleThe effect of systemic antibiotics on the microbiota in the feces during febrile neutropenia in pediatric patients with cancer.
- ACRONYMAntiMic
- hypothesisWhat is the effect of the systemic antibiotic therapy on the number and diversity of specific bacterial groups in fecal samples of pediatric patients with cancer?
- Healt Condition(s) or Problem(s) studiedAntibiotics, Paediatric oncology patients, Fever
- Inclusion criteria- Pediatric patients with cancer hospitalised in University Medical Centre Groningen
- Reason of hospitalization is febrile neutropenia
- Active treatment with systemic antibiotics
- Exclusion criteria- No defecation within the first three days of hospitalization
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 18-jun-2015
- planned closingdate18-jun-2016
- Target number of participants20
- InterventionsCollecting fecal samples obtained from feces in commode chair.
- Primary outcome- Number of specific bacterial groups in feces of pediatric patients
- Secondary outcome- The difference in diversity of the microbiota before and after treatment
- Type of systemic antibiotics
- Laboratory values (Hb, CRP, leukocytes)
- Blood cultures
- Temperature
- Type of nutrition
- TimepointsFirst and last day of treatment with systemic antibiotics.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. W.J.E. Tissing
- CONTACT for SCIENTIFIC QUERIESMD. PhD. W.J.E. Tissing
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryUnbalance between aerobic and anaerobic bacteria in the gastrointestinal tract can result in favoring a potentially pathogenic microorganism, which could cause a bacterial infection. For this reason it is important to identify how systemic broad spectrum antibiotics affect the microbiota during febrile neutropenia in pediatric patients with cancer. To investigate our research question, we will collect feces samples from pediatric patients with cancer during febrile neutropenia in the UMCG at two points during treatment. These samples will be analyzed by using pyrosequencing techniques. We hypothesize that the bacterial content of the gut changes when the patient gets systemic intravenous antibiotics.
- Main changes (audit trail)
- RECORD16-mrt-2016 - 4-jun-2016


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