Trial · NCT03969901
Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
NCT03969901, Phase 2, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2025-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021). Trials, record NCT03969901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03969901
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
- NCT number
- NCT03969901
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 115 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Suspected or Documented Gram-negative Bacterial Infection
- Interventions
- IMI/REL, Active Control, Oral Switch
- First posted
- 2019-05-31
- Last updated
- 2026-02-05
- Other registries' IDs
- eudract:2019-000338-20
- Results first posted
- 2025-05-13
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With One or More Adverse Event (AE) | Up to 28 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with AEs are presented. |
| Primary | Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event (AE) | Up to 14 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study medication due to an AE are presented. |
| Secondary | Percentage of Participants With All-cause Mortality Through Day 28 | Up to Day 28 | For each participant, survival status was assessed at Day 28 post-randomization. The percentage of participants with all-cause mortality through Day 28 is presented. |
| Secondary | Percentage of Participants With a Favorable Clinical Response at End of Therapy (EOT) | Day 5 up to Day 14 | A favorable clinical response at EOT requires an assessment of "cure" or "improved". Cure is defined as all preintervention signs and symptoms of the index infection have resolved (or returned to "preinfection status", with no new symptoms) AND no additional antibacterial intervention is required for the index infection. Improved is defined as the majority of preintervention signs and symptoms of the index infection have improved or resolved (or returned to "preinfection status", with no new symptoms) AND no additional antibacterial intervention is required. The percentage of participants with a favorable clinical response at EOT is presented. |
| Secondary | Percentage of Participants With a Favorable Clinical Response at Early Follow-Up (EFU) | Day 12 up to Day 28 | A favorable clinical response at EFU requires an assessment of "cure" or "sustained cure". Cure is defined as all preintervention signs and symptoms of the index infection have resolved (or returned to "preinfection status", with no new symptoms) AND no additional antibacterial intervention is required for the index infection. Sustained cure is defined as a clinical response for the prior visit (EOT or EFU) being defined as "cure". The percentage of participants with a favorable clinical response at EFU is presented. |
| Secondary | Percentage of Participants With a Favorable Clinical Response at Late Follow-Up (LFU) | Baseline and Day 19 up to Day 42 | A favorable clinical response at LFU requires an assessment of "cure" or "sustained cure". Cure is defined as all preintervention signs and symptoms of the index infection have resolved (or returned to "preinfection status", with no new symptoms) AND no additional antibacterial intervention is required for the index infection. Sustained cure is defined as a clinical response for the prior visit (EOT or EFU) being defined as "cure". The percentage of participants with a favorable clinical response at LFU is presented. |
| Secondary | Percentage of Participants With a Favorable Microbiological Response at End of Therapy (EOT) | Day 5 up to Day 14 | A favorable microbial response is defined as eradication or presumed eradication. Eradication is defined as one of the following: A lower respiratory tract culture taken at the EOT visit shows eradication of the pathogen found at study entry for HABP/VABP; An intra-abdominal culture taken at the EOT visit shows eradication of the pathogen found at study entry for cIAI; A urine culture taken at the EOT visit shows eradication of the uropathogen (reduced to \<103 CFU/mL) found at study entry for cUTI. Presumed eradication is defined as no specimen taken because participant is deemed clinically improved or cured of the pathogen found at study entry. The percentage of participants with a favorable microbial response at EOT is presented. |
| Secondary | Percentage of Participants With a Favorable Microbiological Response at End of Follow-Up (EFU) | Day 12 up to Day 28 | A favorable microbiological response at EFU is defined as eradication or presumed eradication. Eradication is defined as one of the following: A lower respiratory tract culture taken at the EFU visit shows eradication of the pathogen found at study entry for HABP/VABP; An intra-abdominal culture taken at the EFU visit shows eradication of the pathogen found at study entry for cIAI; A urine culture taken at the EFU visit shows eradication of the uropathogen (reduced to \<103 CFU/mL) found at study entry for cUTI. Presumed eradication is defined as no specimen taken because participant is deemed clinically improved or cured of the pathogen found at study entry. The percentage of participants with a favorable microbial response at EFU is presented. |
| Secondary | Percentage of Participants With a Favorable Microbiological Response at Late Follow-Up (LFU) | Day 19 up to Day 42 | A favorable microbiological response at LFU is defined as eradication or presumed eradication. Eradication is defined as one of the following: A lower respiratory tract culture taken at the LFU visit shows eradication of the pathogen found at study entry for HABP/VABP; An intra-abdominal culture taken at the LFU visit shows eradication of the pathogen found at study entry for cIAI; A urine culture taken at the LFU visit shows eradication of the uropathogen (reduced to \<103 CFU/mL) found at study entry for cUTI. Presumed eradication is defined as no specimen taken because participant is deemed clinically improved or cured of the pathogen found at study entry. The percentage of participants with a favorable microbial response at LFU is presented. |
| Secondary | Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of Imipenem Following Administration of IMI/REL | On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day. | AUC0-24 is a measure of the total amount of drug in the plasma from the dose to Hour 24. Blood samples were collected to determine the AUC0-24 of imipenem. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With One or More Adverse Event (AE) | Up to 28 days | All randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event (AE) | Up to 14 days | All randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With All-cause Mortality Through Day 28 | Up to Day 28 | The analysis population included all randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a Favorable Clinical Response at End of Therapy (EOT) | Day 5 up to Day 14 | The analysis population included all randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a Favorable Clinical Response at Early Follow-Up (EFU) | Day 12 up to Day 28 | The analysis population included all randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a Favorable Clinical Response at Late Follow-Up (LFU) | Baseline and Day 19 up to Day 42 | The analysis population included all randomized participants who received at least 1 dose of IV study intervention. Participants were included in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a Favorable Microbiological Response at End of Therapy (EOT) | Day 5 up to Day 14 | For participants with HABP/VABP and cIAI: Has received at least 1 dose of IV study intervention; AND baseline infection-site culture grew at least 1 gram-negative pathogenic organism. For participants with cUTI: Has received at least 1 dose of IV study intervention; AND baseline urine culture grew at least 1 gram-negative pathogenic organism at sufficient quantity (ie, growth at ≥105 CFU/mL of uropathogen). Participants were included in the intervention group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a Favorable Microbiological Response at End of Follow-Up (EFU) | Day 12 up to Day 28 | For participants with HABP/VABP and cIAI: Has received at least 1 dose of IV study intervention; AND baseline infection-site culture grew at least 1 gram-negative pathogenic organism. For participants with cUTI: Has received at least 1 dose of IV study intervention; AND baseline urine culture grew at least 1 gram-negative pathogenic organism at sufficient quantity (ie, growth at ≥105 CFU/mL of uropathogen). Participants were included in the intervention group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With a Favorable Microbiological Response at Late Follow-Up (LFU) | Day 19 up to Day 42 | For participants with HABP/VABP and cIAI: Has received at least 1 dose of IV study intervention; AND baseline infection-site culture grew at least 1 gram-negative pathogenic organism. For participants with cUTI: Has received at least 1 dose of IV study intervention; AND baseline urine culture grew at least 1 gram-negative pathogenic organism at sufficient quantity (ie, growth at ≥105 CFU/mL of uropathogen). Participants were included in the intervention group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of Imipenem Following Administration of IMI/REL | On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day. | The analysis population includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample. | µM*hr | GEOMETRIC_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group115
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With One or More Adverse Event (AE) | IMI/REL Age Cohort 1: Adolescents (12 to <18 Years) | 60.0 | Percentage of Participants | ||
| Percentage of Participants With One or More Adverse Event (AE) | Active Control Cohort 1: Adolescents: (12 to <18 Years) | 50.0 | Percentage of Participants | ||
| Percentage of Participants With One or More Adverse Event (AE) | IMI/REL Age Cohort 2: Older Children (6 to <12 Years) | 64.5 | Percentage of Participants | ||
| Percentage of Participants With One or More Adverse Event (AE) | Active Control Age Cohort 2: Older Children (6 to <12 Years) | 36.4 | Percentage of Participants | ||
| Percentage of Participants With One or More Adverse Event (AE) | IMI/REL Age Cohort 3: Younger Children (2 to <6 Years) | 71.4 | Percentage of Participants | ||
| Percentage of Participants With One or More Adverse Event (AE) | Active Control Age Cohort 3: Younger Children (2 to <6 Years) | 62.5 | Percentage of Participants | ||
| Percentage of Participants With One or More Adverse Event (AE) | IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years) | 93.3 | Percentage of Participants | ||
| Percentage of Participants With One or More Adverse Event (AE) | Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years) | 50.0 | Percentage of Participants | ||
| Percentage of Participants With One or More Adverse Event (AE) | IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months) | 25.0 | Percentage of Participants | ||
| Percentage of Participants With One or More Adverse Event (AE) | Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months) | 66.7 | Percentage of Participants |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IMI/REL Age Cohort 1: Adolescents (12 to <18 Years) | 10 | |
| Overall Study | STARTED | Active Control Age Cohort 1: Adolescents (12 to <18 Years) | 2 | |
| Overall Study | STARTED | IMI/REL Age Cohort 2: Older Children (6 to <12 Years) | 31 | |
| Overall Study | STARTED | Active Control Age Cohort 2: Older Children (6 to <12 Years) | 11 | |
| Overall Study | STARTED | IMI/REL Age Cohort 3: Younge Children (2 to <6 Years) | 22 | |
| Overall Study | STARTED | Active Control Age Cohort 3: Younger Children (2 to <6 Years) | 8 | |
| Overall Study | STARTED | IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years) | 15 | |
| Overall Study | STARTED | Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years) | 5 | |
| Overall Study | STARTED | IMI/REL Age Cohort 5 Neonates and Young Infants (Birth to <3 Months) | 8 | |
| Overall Study | STARTED | Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months) | 3 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events730
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 | Anaemia | Blood and lymphatic system disorders | IMI/REL Age Cohort 1: Adolescents (12 to <18 Years) | 0 | 10 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Active Control Age Cohort 1: Adolescents (12 to <18 Years) | 0 | 2 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | IMI/REL Age Cohort 2: Older Children (6 to <12 Years) | 0 | 31 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Active Control Age Cohort 2: Older Children (6 to <12 Years) | 0 | 11 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | IMI/REL Age Cohort 3: Younger Children (2 to <6 Years) | 1 | 21 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Active Control Age Cohort 3: Younger Children (2 to <6 Years) | 0 | 8 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years) | 1 | 15 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years) | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months) | 0 | 8 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months) | 0 | 3 | 0 |
1 to 10 of 730Source ClinicalTrials.gov
See all 730 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IMI/REL Age Cohort 1: Adolescents (12 to <18 Years) | 0 | 10 |
| Total, all-cause mortality | Active Control Age Cohort 1: Adolescents (12 to <18 Years) | 0 | 2 |
| Total, all-cause mortality | IMI/REL Age Cohort 2: Older Children (6 to <12 Years) | 0 | 31 |
| Total, all-cause mortality | Active Control Age Cohort 2: Older Children (6 to <12 Years) | 0 | 11 |
| Total, all-cause mortality | IMI/REL Age Cohort 3: Younger Children (2 to <6 Years) | 0 | 22 |
| Total, all-cause mortality | Active Control Age Cohort 3: Younger Children (2 to <6 Years) | 0 | 8 |
| Total, all-cause mortality | IMI/REL Age Cohort 4: Infants and Toddlers (3 Months to <2 Years) | 0 | 15 |
| Total, all-cause mortality | Active Control Age Cohort 4: Infants and Toddlers (3 Months to <2 Years) | 0 | 5 |
| Total, all-cause mortality | IMI/REL Age Cohort 5: Neonates and Young Infants (Birth to <3 Months) | 0 | 8 |
| Total, all-cause mortality | Active Control Age Cohort 5: Neonates and Young Infants (Birth to <3 Months) | 0 | 3 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42400209 | DERIVED |
Source PubMed
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.
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