IMI/REL for Gram-Negative Bacterial Infection

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hippokration General Hospital of Thessaloniki ( Site 0244), Thessaloniki, GreeceGram-Negative Bacterial InfectionIMI/REL - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying the safety and effectiveness of a new drug, imipenem/cilastatin/relebactam, in children up to 18 years old who have a confirmed or suspected bacterial infection.

Eligible Conditions
  • Gram-Negative Bacterial Infection

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 12 Secondary · Reporting Duration: 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.

Day 1
Concentration at End of Infusion (Ceoi) of Imipenem Following Administration of IMI/REL
Concentration at End of Infusion (Ceoi) of Relabactam Following Administration of IMI/REL
Day 28
Percentage of Participants With a Favorable Clinical Response at Early Follow-Up (EFU)
Percentage of Participants With a Favorable Microbiological Response at End of Follow-Up (EFU)
Day 42
Percentage of Participants With a Favorable Clinical Response at Late Follow-Up (LFU)
Percentage of Participants With a Favorable Microbiological Response at Late Follow-Up (LFU)
Day 14
Percentage of Participants With a Favorable Clinical Response at End of Therapy (EOT)
Percentage of Participants With a Favorable Microbiological Response at End of Therapy (EOT)
Day 3
Imipenem
Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of Relebactam Following Administration of IMI/REL
Percentage of Time Imipenem Concentration Is Above Minimum Inhibitory Concentration (%T>MIC of Imipenem) Following Administration of IMI/REL
Up to 14 days
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event (AE)
Up to 28 days
Percentage of Participants With One or More Adverse Event (AE)
Up to Day 28
Number of Deaths by All Causes Through Day 28

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Vabomere
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Oritavancin
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IV Tedizolid Phosphate

Side Effects for

cIAI/cUTI
9%Diarrhoea
9%Nausea
6%Nasopharyngitis
2%Abdominal abscess
1%Renal haematoma
1%Rhegmatogenous retinal detachment
1%Large intestine perforation
1%Pancreatitis acute
1%Cholecystitis acute
1%Pelvic abscess
1%Peritonitis
1%Postoperative ileus
1%Acute kidney injury
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT03293485) in the cIAI/cUTI ARM group. Side effects include: Diarrhoea with 9%, Nausea with 9%, Nasopharyngitis with 6%, Abdominal abscess with 2%, Renal haematoma with 1%.

Trial Design

2 Treatment Groups

Active Control
1 of 2
IMI/REL
1 of 2

Active Control

Experimental Treatment

140 Total Participants · 2 Treatment Groups

Primary Treatment: IMI/REL · No Placebo Group · Phase 2 & 3

IMI/REL
Drug
Experimental Group · 1 Intervention: IMI/REL · Intervention Types: Drug
Active Control
Drug
ActiveComparator Group · 1 Intervention: Active Control · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,577,982 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,707 Previous Clinical Trials
4,967,118 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,654 Previous Clinical Trials
7,957,106 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 4 Total Inclusion Criteria

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References

Frequently Asked Questions

Are there any open spots for patients in this clinical trial?

"That is correct, the listing on clinicaltrials.gov affirms that this trial is still active and looking for participants. The trial was first advertised on October 8th, 2019 and has been updated as recently as September 15th, 2020. They are hoping to enroll 140 patients total at 3 locations." - Anonymous Online Contributor

Unverified Answer
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