Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections).

A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/03/004513

Enrollment

964

Registered

2014-03-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis. Health Condition 2: N390- Urinary tract infection, site notspecified

Interventions

Intervention1: Drug 1: CAZ-AVI Drug 2: Doripenem : Patients are randomized to either CAZ-AVI or Doripenem as active treatment. Both CAZ-AVI and Doripenem are given via IV infusion every 8 hours. Tota

Doripenem). Intervention2: Drug: Doripenem: 500 mg of Doripenem Control Intervention1: Drug 1: Ciprofloxacin Drug 2: Sulfamethoxazole/ trimethoprim: The protocol also allows subjects to switch to ora

Sulfamethoxazole/trimethoprim). Control Intervention2: Drug: or 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral): 800 mg/160 mg of sulfamethoxazole/trimethoprim

Eligibility

Inclusion criteria

Inclusion criteria: 18 to 65 years of age inclusive. Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 28 days after. Has pyuria with greather than or equal 10 WBCs and has a positive urine culture within 48 hours of enrollment containing greather than or equal 10 to the fifth CFU/ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem). Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis.

Exclusion criteria

Exclusion criteria: Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem. Patient urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI. Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant. Patient is immunocompromised. Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness.

Design outcomes

Primary

Measure	Time frame
1.The proportion of patients with resolved (or return to premorbid) UTI(Urinary Tract Infection)symptoms except flank pain and resolution or improvement in flank pain based on patient-reported symptom assessment response. 2.The proportion of patients with a per patient microbiological eradication and resolution (or return to premorbid) of all UTI-specified symptoms based on patient-reported symptom assessment response.Timepoint: 1.Day 5 after study drug start. 2.21 to 25 day after randomization.	—

Measure

Time frame

1.The proportion of patients with resolved (or return to premorbid) UTI(Urinary Tract Infection)symptoms except flank pain and resolution or improvement in flank pain based on patient-reported symptom assessment response. 2.The proportion of patients with a per patient microbiological eradication and resolution (or return to premorbid) of all UTI-specified symptoms based on patient-reported symptom assessment response.Timepoint: 1.Day 5 after study drug start. 2.21 to 25 day after randomization.

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Secondary

Measure	Time frame
Profile of pharmacokinetic (PK) of the individual components of CAZ-AVI (avibactam and ceftazidime)- area under the plasma concentration time curve at steady state (AUCss). AUCss - Area under the plasma concentration time curve at steady state. Timepoint: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.;Profile of pharmacokinetic (PK) of the individual components of CAZ-AVI (avibactam and ceftazidime)- maximum plasma concentration (Cmax). Cmax - Maximum plasma concentration. Timepoint: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.;Profile of pharmacokinetic (PK) of the individual components of CAZ-AVI (avibactam and ceftazidime)- minimum plasma concentration (Cmin). Cmin - Minimum plasma concentration. Timepoint: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.;Profile of pharmacokinetic (PK) of the individual components of CAZ-AVI (avibactam and ceftazidime)- terminal half-life (tÂ½ ). tÂ½ - Terminal half-life. Timepoint: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.;The favorable per pathogen microbiologic response by categories of minimum inhibitory concentration in the extended microbiologically evaluable analysis set.Timepoint: 24 hours after completion of study drug, 21 to 25 days and 45 to 52 days after the start of the study drug.;The favorable per pathogen microbiologic response by categories of minimum inhibitory concentration in the microbiological modified Intent-	—

Measure

Time frame

Profile of pharmacokinetic (PK) of the individual components of CAZ-AVI (avibactam and ceftazidime)- area under the plasma concentration time curve at steady state (AUCss). AUCss - Area under the plasma concentration time curve at steady state. Timepoint: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.;Profile of pharmacokinetic (PK) of the individual components of CAZ-AVI (avibactam and ceftazidime)- maximum plasma concentration (Cmax). Cmax - Maximum plasma concentration. Timepoint: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.;Profile of pharmacokinetic (PK) of the individual components of CAZ-AVI (avibactam and ceftazidime)- minimum plasma concentration (Cmin). Cmin - Minimum plasma concentration. Timepoint: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.;Profile of pharmacokinetic (PK) of the individual components of CAZ-AVI (avibactam and ceftazidime)- terminal half-life (tÂ½ ). tÂ½ - Terminal half-life. Timepoint: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.;The favorable per pathogen microbiologic response by categories of minimum inhibitory concentration in the extended microbiologically evaluable analysis set.Timepoint: 24 hours after completion of study drug, 21 to 25 days and 45 to 52 days after the start of the study drug.;The favorable per pathogen microbiologic response by categories of minimum inhibitory concentration in the microbiological modified Intent-

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Countries

Argentina, Belgium, Brazil, Bulgaria, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Japan, Mexico, Poland, Republic of Korea, Romania, Russian Federation, Taiwan, Ukraine, United States of America

Contacts

Public ContactArun Sundriyal

PPD Pharmaceutical Development India Pvt. Ltd.

Arun.Sundriyal@ppdi.com911244739903

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026