Trial · NCT01110421
A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia
NCT01110421, 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 Hospitalized Children With Bacterial Pneumonia. Trials, record NCT01110421. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01110421
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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 Hospitalized Children With Bacterial Pneumonia
- NCT number
- NCT01110421
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 7 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Pneumonia, Bacterial, Community-Acquired Infections, Nosocomial Infection, Pneumonia, Ventilator-Associated
- Interventions
- Cefepime placebo, Cefepime, Doripenem, Doripenem placebo, Amoxicillin/clavulanate potassium
- First posted
- 2010-04-26
- Last updated
- 2014-07-15
- Other registries' IDs
- eudract:2009-016069-27
- 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 of signs and symptoms of pneumonia, favorable response at End of treatment for IV study (EIV) visit; had no fever; improvement or no progression of radiographic findings of pneumonia on chest X ray; improvement in oxygenation or discontinued mechanical ventilation in intubated participants; and not received nonstudy systemic antibacterial therapy for pneumonia. |
| 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) | Participants were considered as clinical improved if they had no fever, clinical improvement in signs and symptoms of pneumonia from baseline, decrease in WBC, improvement or lack of progression of radiographic findings in comparison with the screening chest X-ray, and not received any nonstudy systemic antibacterial therapy for the treatment of pneumonia 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 showed no evidence of resurgence after administration of the last dose of study medication and no nonstudy systemic antibacterial therapy was given for the treatment of pneumonia. |
| Secondary | The Number of Participants With Favorable Per-participant Microbiological Response Rate | 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) | A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). 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). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis. |
| 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) | A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). 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). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis. |
| 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) | A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). 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). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis. |
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 pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract culture, pleural fluid or blood 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: All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract culture, pleural fluid or blood 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 pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract (LRT) culture, pleural fluid or blood culture. | Participants | NUMBER |
| SECONDARY | The Number of Participants With Favorable Per-participant Microbiological Response Rate | 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 CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia 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 CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia 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 CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia 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 CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
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 | 3 | Participants | ||
| The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit | Cefepime | 2 | Participants | ||
| The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit | Doripenem | 4 | Participants | ||
| The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit | Cefepime | 2 | Participants | ||
| The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit | Doripenem | 3 | Participants | ||
| The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit | Cefepime | 2 | Participants | ||
| The Number of Participants With Favorable Per-participant Microbiological Response Rate | Doripenem | TOC visit | 2 | Participants | |
| The Number of Participants With Favorable Per-participant Microbiological Response Rate | Doripenem | EIV visit | 2 | Participants | |
| The Number of Participants With Favorable Per-participant Microbiological Response Rate | Doripenem | LFU visit | 2 | Participants | |
| Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit | Doripenem | Staphylococcus aureus (1) | 1 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 | 5 | |
| Overall Study | STARTED | Cefepime | 2 | |
| Overall Study | COMPLETED | Doripenem | 5 | |
| Overall Study | COMPLETED | Cefepime | 2 | |
| Overall Study | NOT COMPLETED | Doripenem | 0 | |
| Overall Study | NOT COMPLETED | Cefepime | 0 |
Source ClinicalTrials.gov
Adverse events32
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 | Abdominal Pain | Gastrointestinal disorders | Doripenem | 1 | 5 | |
| other | Abdominal Pain | Gastrointestinal disorders | Cefepime | 0 | 2 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Doripenem | 1 | 5 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Cefepime | 0 | 2 | |
| other | Diarrhoea | Gastrointestinal disorders | Doripenem | 1 | 5 | |
| other | Diarrhoea | Gastrointestinal disorders | Cefepime | 0 | 2 | |
| other | Chest Pain | General disorders | Doripenem | 1 | 5 | |
| other | Chest Pain | General disorders | Cefepime | 0 | 2 | |
| other | Hypersensitivity | Immune system disorders | Doripenem | 1 | 5 | |
| other | Hypersensitivity | Immune system disorders | Cefepime | 0 | 2 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 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 | 3 | 5 |
| Total, other adverse events | Cefepime | 1 | 2 |
| Total, serious adverse events | Doripenem | 2 | 5 |
| Total, serious adverse events | Cefepime | 0 | 2 |
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/NCT01110421
GET https://conductscience.org/api/trials/v1/NCT01110421/events?page=2