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IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis

NCT03757234 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2020-07-07

Study results available
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Summary

The purpose of this study was to evaluate the safety and efficacy of intravenous (iv) or iv/per oral (po) omadacycline as compared to iv or iv/po levofloxacin in the treatment of female adults with acute pyelonephritis.

Conditions

  • Acute Pyelonephritis

Interventions

DRUG

Omadacycline

po tablets

DRUG

Levofloxacin

iv solution/po tablets

DRUG

Omadacycline

iv solution

Sponsors & Collaborators

  • Paratek Pharmaceuticals Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2019-06-26
Completion
2019-07-24
FDA Drug
Yes

Countries

  • Georgia
  • Latvia
  • Russia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03757234 on ClinicalTrials.gov