Trial · NCT03019965
Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis
NCT03019965, Not applicable, Completed, Coordinación de Investigación en Salud, Mexico; results first posted 2021-08-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis. Trials, record NCT03019965. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03019965
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis
- NCT number
- NCT03019965
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 426 participants, actual
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Conditions
- Sepsis
- Interventions
- Intermittent Piperacillin/tazobactam, Continuous Piperacillin/tazobactam, Intermittent Imipenem, Extended Imipenem, Intermittent Meropenem, Extended Meropenem
- First posted
- 2017-01-13
- Last updated
- 2021-08-05
- Results first posted
- 2021-08-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Response | Number of participants with clinical response at 14 days after antibiotic cessation, up to an average of 28 days or the day of your discharge if this occurred before 14 days after antibiotic cessation. | Resolution. Disappearance of all signs and symptoms related to the infection. Failure. Insufficient lessening of the signs and symptoms of infection to qualify as improvement, including death or indeterminate (no evaluation possible, for any reason). |
| Secondary | Number of Participants With Adverse Events | Number of participants with adverse events evaluated by an physician at the time of administration of antibiotics, up to an average to 24 hours after the study drug cessation. | Any harmful, undesirable, potentially serious and life threatening effects occurring during or after administration of the antibiotics proposed in this study (piperacillin / tazobactam, imipenem or meropenem), was evaluated as: none or adverse event classified according to the intensity of the clinical manifestation (severity) as: mild, moderate or severe and for each antibiotic. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinical Response | Number of participants with clinical response at 14 days after antibiotic cessation, up to an average of 28 days or the day of your discharge if this occurred before 14 days after antibiotic cessation. | The efficacy of the maneuver was evaluated by frequency of clinical response and calculation of the absolute risk reduction and the number needed to treat. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events | Number of participants with adverse events evaluated by an physician at the time of administration of antibiotics, up to an average to 24 hours after the study drug cessation. | evaluation of the safety of the intervention with analysis of the frequency of adverse events by treatment group | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical Response | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | 178 | Participants | ||
| Number of Participants With Clinical Response | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | 169 | Participants | ||
| Number of Participants With Adverse Events | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | 1 | Participants | ||
| Number of Participants With Adverse Events | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | 3 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | 211 | |
| Overall Study | STARTED | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | 215 | |
| Overall Study | COMPLETED | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | 201 | |
| Overall Study | COMPLETED | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | 202 | |
| Overall Study | NOT COMPLETED | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | 10 | |
| Overall Study | NOT COMPLETED | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | 13 |
Source ClinicalTrials.gov
Adverse events2
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 | moderate adverse event | Gastrointestinal disorders | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | 1 | 201 | 1 |
| other | moderate adverse event | Gastrointestinal disorders | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | 3 | 202 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | 17 | 201 |
| Total, all-cause mortality | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | 19 | 202 |
| Total, other adverse events | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | 1 | 201 |
| Total, other adverse events | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | 3 | 202 |
| Total, serious adverse events | Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem | 0 | 201 |
| Total, serious adverse events | Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem | 0 | 202 |
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 |
|---|---|
Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem vs Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem: Number of Participants With Clinical Response | Trial comparisons |
| Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem vs Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem: Number of Participants With Adverse Events | Trial comparisons |
| Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem vs Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem: deaths from any cause | Trial comparisons |
| Intermittent. Piperacillin/Tazobactam, Imipenem, Meropenem vs Prolonged Infusion. Continuous Piperacillin/Tazobactam, Extended Imipenem, Extended Meropenem: 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/NCT03019965
GET https://conductscience.org/api/trials/v1/NCT03019965/registered