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NCT02166476 · ClinicalTrials.gov registry record · Phase 3

Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP

A Phase 3 study, sponsored by Melinta Therapeutics.

Completed
Registry status
Phase 3
Development phase
550
Enrollment target

NCT02166476: Completed Phase 3 study, sponsored by Melinta Therapeutics.

NCT02166476 is a Phase 3 study that has completed, run by Melinta Therapeutics. The registered enrollment target is 550 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02166476, a Phase 3 study, has completed, sponsored by Melinta Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
550 participants
Enrollment target

Study Summary

Meropenem-vaborbactam is being compared to piperacillin-tazobactam in the treatment of adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP).

Primary Outcome

This was the primary outcome measure for the Food and Drug Administration (FDA). For this composite outcome measure, overall success was achieved with a clinical outcome of Cure or Improvement and microbiologic outcome of Eradication at the end of intravenous treatment (EOIVT). Cure was defined as the complete resolution or significant improvement of the baseline signs and symptoms. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms. E

Interventions

  • DRUG Saline
  • DRUG Meropenem-Vaborbactam
  • DRUG Levofloxacin
  • DRUG Piperacillin-Tazobactam

Trial Details

FieldValue
Enrollment Target 550 participants
Start Date 2014-11-20
Est. Completion 2016-04-28
Phase Phase 3
Melinta Therapeutics

31 total trials

What the finished NCT02166476 record still lists

NCT02166476 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower).

The record links to 0 conditions, and to 4 interventions - of which Saline is the first listed.

NCT02166476 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02166476 about?

NCT02166476 is a clinical study titled "Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP". Meropenem-vaborbactam is being compared to piperacillin-tazobactam in the treatment of adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP).

What is the current status of trial NCT02166476?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 550 participants. The study started on 2014-11-20. Estimated completion is 2016-04-28.

What interventions are being tested in trial NCT02166476?

The interventions under investigation include: Saline (DRUG), Meropenem-Vaborbactam (DRUG), Levofloxacin (DRUG), Piperacillin-Tazobactam (DRUG).

Who is sponsoring clinical trial NCT02166476?

This trial is sponsored by Melinta Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02166476's enrollment target sits among peer trials

550 680th of 2000 higher than 1,312 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02166476, the US trial registry maintained by the National Library of Medicine. NCT02166476 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.