Trial · NCT01110408
A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections
NCT01110408, Phase 3, Terminated, Janssen Research & Development, LLC; results first posted 2014-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections. Trials, record NCT01110408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01110408
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections
- NCT number
- NCT01110408
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 41 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Complicated Urinary Tract Infections or Pyelonephritis
- Interventions
- Doripenem, Doripenem placebo, Cefepime, Cefepime placebo, Amoxicillin/clavulanate potassium
- First posted
- 2010-04-26
- Last updated
- 2014-07-15
- Results first posted
- 2014-07-02
- Limitations and caveats
This study was terminated early due to business reasons and not related to safety concerns or issues. As such, the limited enrollment precludes a meaningful conclusion about the efficacy and safety of doripenem compared with cefepime.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit | TOC (7 to 14 days after the last dose of study medication therapy) | The participants were classified as cure if they had resolution or clinical improvement in signs and symptoms of complicated urinary tract infection; had no fever; no additional antimicrobial therapy was required for the treatment of the infection; and a clinical response assessment of improvement at End of IV visit. |
| Secondary | The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit | EIV (within 24 hours after completion of the last dose of IV study medication therapy) | The participants were considered as clinical improved if they had clinical improvement in signs and symptoms from baseline; no fever for at least the 24 hours before discontinuing the IV study drug; and not received nonstudy antibiotics for the treatment of urinary tract infection after IV study drug therapy had begun. |
| Secondary | The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit | LFU (28 to 42 days after the last dose of study medication therapy) | The participants were classified as clinical cure if all pretreatment signs and symptoms of complicated urinary tract infection showed no evidence of recurrence after test of cure. |
| Secondary | The Number of Participants With Favorable Per-participant Microbiological Response | EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy) | Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). |
| Secondary | Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit | EIV (within 24 hours after completion of the last dose of IV study medication therapy) | The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively). |
| Secondary | Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit | TOC (7 to 14 days after the last dose of study medication therapy) | The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively). |
| Secondary | Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit | LFU (28 to 42 days after the last dose of study medication therapy) | The sustained favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit | TOC (7 to 14 days after the last dose of study medication therapy) | Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture. | Participants | NUMBER |
| SECONDARY | The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit | EIV (within 24 hours after completion of the last dose of IV study medication therapy) | Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture. | Participants | NUMBER |
| SECONDARY | The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit | LFU (28 to 42 days after the last dose of study medication therapy) | Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture. | Participants | NUMBER |
| SECONDARY | The Number of Participants With Favorable Per-participant Microbiological Response | EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy) | Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set. | Participants | NUMBER |
| SECONDARY | Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit | EIV (within 24 hours after completion of the last dose of IV study medication therapy) | Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set. | Participants | NUMBER |
| SECONDARY | Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit | TOC (7 to 14 days after the last dose of study medication therapy) | Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set. | Participants | NUMBER |
| SECONDARY | Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit | LFU (28 to 42 days after the last dose of study medication therapy) | Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit | Doripenem | 20 | Participants | ||
| The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit | Cefepime | 5 | Participants | ||
| The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit | Doripenem | 28 | Participants | ||
| The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit | Cefepime | 10 | Participants | ||
| The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit | Doripenem | 18 | Participants | ||
| The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit | Cefepime | 5 | Participants | ||
| The Number of Participants With Favorable Per-participant Microbiological Response | Doripenem | EIV visit | 24 | Participants | |
| The Number of Participants With Favorable Per-participant Microbiological Response | Cefepime | EIV visit | 8 | Participants | |
| The Number of Participants With Favorable Per-participant Microbiological Response | Doripenem | TOC visit | 19 | Participants | |
| The Number of Participants With Favorable Per-participant Microbiological Response | Cefepime | TOC visit | 4 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Doripenem | 31 | |
| Overall Study | STARTED | Cefepime | 10 | |
| Overall Study | COMPLETED | Doripenem | 30 | |
| Overall Study | COMPLETED | Cefepime | 10 | |
| Overall Study | NOT COMPLETED | Doripenem | 1 | |
| Overall Study | NOT COMPLETED | Cefepime | 0 |
Source ClinicalTrials.gov
Adverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Doripenem | 3 | 30 | |
| other | Vomiting | Gastrointestinal disorders | Cefepime | 0 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | Doripenem | 2 | 30 | |
| other | Diarrhoea | Gastrointestinal disorders | Cefepime | 0 | 10 | |
| other | Pyrexia | General disorders | Doripenem | 3 | 30 | |
| other | Pyrexia | General disorders | Cefepime | 1 | 10 | |
| other | Infusion Site Pain | General disorders | Doripenem | 0 | 30 | |
| other | Infusion Site Pain | General disorders | Cefepime | 1 | 10 | |
| other | Vessel Puncture Site Pain | General disorders | Doripenem | 0 | 30 | |
| other | Vessel Puncture Site Pain | General disorders | Cefepime | 1 | 10 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doripenem | ||
| Total, all-cause mortality | Cefepime | ||
| Total, other adverse events | Doripenem | 11 | 30 |
| Total, other adverse events | Cefepime | 6 | 10 |
| Total, serious adverse events | Doripenem | 1 | 30 |
| Total, serious adverse events | Cefepime | 3 | 10 |
Source ClinicalTrials.gov
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Doripenem vs Cefepime: The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit | Trial comparisons |
| Doripenem vs Cefepime: The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit | Trial comparisons |
| Doripenem vs Cefepime: The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit | Trial comparisons |
| Doripenem vs Cefepime: serious adverse events | Trial comparisons |
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/NCT01110408
GET https://conductscience.org/api/trials/v1/NCT01110408/results?page=2