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Carbapenem

Ertapenem + Zidebactam for Bacterial Infection

Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Note 1: Barrier contraception includes use of condom with spermicide.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 11
Awards & highlights

Study Summary

This trial is assessing the safety and tolerability of a combination of two medicines and their individual doses in healthy adults.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You need to use a condom with spermicide as a form of birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 11
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events (AEs)
Incidence of treatment-emergent serious adverse events (SAEs)
Secondary outcome measures
Calculated exposure in plasma for Ertapenem (ERT)
Calculated exposure in plasma for Zidebactam (ZID)
Calculated exposure in urine for Ertapenem (ERT)
+1 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Cohort 7Experimental Treatment4 Interventions
WCK 6777 (Ertapenem 3 g combined with Zidebactam 3 g) or placebo administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days. N=8
Group II: Cohort 6Experimental Treatment1 Intervention
Zidebactam 3 g administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days. N=6
Group III: Cohort 5Experimental Treatment2 Interventions
Ertapenem 3 g or placebo administered by 250 ml of intravenous infusion (IV) for 2 hours, once daily, for 7 days. N=8
Group IV: Cohort 4Experimental Treatment4 Interventions
WCK 6777 (Ertapenem 2 g combined with Zidebactam 2 g) or placebo administered by 250 ml of intravenous infusion (IV) for 1 hour, once daily, for 7 days. N=8
Group V: Cohort 3Experimental Treatment1 Intervention
Zidebactam 2 g administered by 250 ml of intravenous infusion (IV) for 1 hour,once daily,for 7 days. N=6
Group VI: Cohort 2Experimental Treatment2 Interventions
Ertapenem 2 g or placebo administered by 250 ml of intravenous infusion (IV) for 1 hour once daily for 7 days. N=8
Group VII: Cohort 1Experimental Treatment4 Interventions
WCK 6777 (Ertapenem 1 g combined with Zidebactam 1 g) or placebo administered by 100 ml of intravenous infusion (IV) for 30 (±5) minutes once daily for 7 days. N= 8
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ertapenem
2011
Completed Phase 4
~8070
WCK 6777
2023
Completed Phase 1
~60
Zidebactam
2023
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,261 Previous Clinical Trials
5,482,952 Total Patients Enrolled

Media Library

Ertapenem (Carbapenem) Clinical Trial Eligibility Overview. Trial Name: NCT05645757 — Phase 1
Bacterial Infection Research Study Groups: Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7
Bacterial Infection Clinical Trial 2023: Ertapenem Highlights & Side Effects. Trial Name: NCT05645757 — Phase 1
Ertapenem (Carbapenem) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05645757 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this clinical trial restricted to a certain age group?

"The lower limit of eligibility for this research is 18 years old while the upper boundary resides at 45."

Answered by AI

What risks do participants in Cohort 5 face?

"There is a lack of evidence to support Cohort 5's safety and efficacy, leading our team at Power to rate it as a 1 on the risk scale."

Answered by AI

Has recruitment for this clinical trial already begun?

"As indicated on clinicaltrials.gov, this trial is no longer searching for new patients to participate in the study. The medical research was first posted on December 12th 2022 and had its last update 15 days later. Fortunately, there are presently 64 other trials that are actively recruiting candidates at present time."

Answered by AI

What are the criteria for eligibility in this investigation?

"This trial is open to adults aged 18-45 who have bacterial infections. They must also be in good general health, possess suitable veins for cannulation or venipuncture, and meet a variety of other requirements listed on FDA Form 1572. Non-pregnant women participants are expected to use an effective method of contraception from screening until 30 days after the last dose of medication is administered."

Answered by AI
~28 spots leftby Mar 2025