Trial · NCT04876131
Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children
NCT04876131, Phase 4, Recruiting, Murdoch Childrens Research Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children. Trials, record NCT04876131. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04876131
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children
- NCT number
- NCT04876131
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 396 participants, estimated
- Lead sponsor
- Murdoch Childrens Research Institute
- Conditions
- Complicated Urinary Tract Infection, Infection, Pediatric Infectious Disease
- Interventions
- Benzylpenicillin - single dose, Benzylpenicillin - three days, Gentamicin - single dose, Gentamicin - three days, Cefalexin - post single dose of IV antibiotics for the remaining two days
- First posted
- 2021-05-06
- Last updated
- 2026-10-09
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Risk difference between 1 dose and 3 doses IV in the proportion of participants with clinical failure at 72 hours | 72 hours | Clinical failure is defined as persistence of baseline symptoms (fever, vomiting or rigors) or development of new symptoms (fever, vomiting or rigors) attributable to UTI at 72 hours. Assessment of clinical failure to be conducted at least 6 hours after antipyretic. Presence of fever, vomiting, or rigors reported by parents within 6 hours of assessment will be recorded as present at assessment. |
| Secondary | Risk difference between 1 dose and 3 doses IV in the proportion of participants readmitted or attending the ED within 14 days of the initial dose of IV antibiotic. | 14 days | Proportion of readmissions within 14 days of the initial dose of IV antibiotics due to persistent fever, vomiting, rigors, or clinical deterioration (eg poor feeding, dehydration) that can be attributable to the UTI |
| Secondary | Risk difference between 1 dose and 3 doses IV in the proportion of participants readmitted or attending the ED within 1 month of the initial dose of IV antibiotics | 1 month | Proportion of readmission within 1 month of the initial dose of IV antibiotics due to persistent fever, vomiting, rigors, or clinical deterioration (eg poor feeding, dehydration) that can be attributable to the UTI. |
| Secondary | Risk difference between 1 dose and 3 doses IV in proportion of participants transferred from HITH or ambulatory care to ward care within 72 hours of initial dose of IV antibiotics. | 72 hours | Proportions of participants transferred from HITH or ambulatory care to ward care within 72 hours of initial dose of IV antibiotics. |
| Secondary | Risk difference between 1 dose and 3 doses IV in the proportion of participants with parental reported improvement | 72 hours | Proportion of patients who are reported as 'generally improved/better' at 72 hours of the initial IV antibiotic dose. This will be reported via the daily diary completed by the parent on day 1, 2 and 3. |
| Secondary | Mean difference between 1 dose and 3 doses IV in duration of IV antibiotics usage | 7 days | Mean difference between 1 dose and 3 doses IV group in duration (number of days up to 1 decimal point) of IV antibiotics, i.e. mean time difference from first dose of IV antibiotics to last dose of IV antibiotics |
| Secondary | Mean difference between 1 dose and 3 doses IV in duration of oral antibiotic usage. | 14 days | Mean difference between 1 dose and 3 doses IV in the duration (number of days up to 1 decimal point) of oral antibiotics administered to patients, i.e mean time difference between last dose of IV antibiotics and the last dose of oral antibiotics. |
| Secondary | Risk difference between 1 dose and 3 doses IV in the proportion of participants with recurrence of UTI symptoms within 14 days of initial dose of IV antibiotics | 14 days | Risk difference between 1 dose and 3 doses IV in the proportion of participants with recurrence of UTI symptoms within 14 days of the first dose of IV antibiotics. Recurrence of symptoms depends on what symptoms the patient initially presented with but may be classified as recurrence of fever, vomiting, rigors or tachycardia. |
| Secondary | Risk difference between 1 dose and 3 doses IV in the proportion of participants with recurrence of UTI symptoms within 1 month of initial dose of IV antibiotics | 1 month | Risk difference between 1 dose and 3 doses IV in the proportion of participants with recurrence of UTI symptoms within 1 month of initial dose of IV antibiotics. Recurrence of symptoms depends on what symptoms the patient initially presented with but may be classified as recurrence of fever, vomiting, rigors or tachycardia. |
| Secondary | Risk difference in the proportion of participants with complications within 14 days of initial dose of IV antibiotics | 14 days | Risk difference in the proportion of participants with complications within 14 days of initial dose of IV antibiotics. Complications are defined as abscess, sepsis, meningitis from the initial IV antibiotics dose to 14 days after the initial dose that are attributable to the UTI as judged by a clinician. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04876131
GET https://conductscience.org/api/trials/v1/NCT04876131/registered