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Clinical trialNCT01345929CompletedPhase 3Interventional

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

SponsorCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Enrollment558Complicated Urinary Tract InfectionPyelonephritis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis).
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Obiamiwe Umeh, M.D., MSc.

    Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    Study Director
    clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

76 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Brazil
  • Facility name not stated

    Belo Horizonte, Minas Gerais, Brazil

  • Facility name not stated

    Porto Alegre, Rio Grande de Sul, Brazil

  • Facility name not stated

    Joinville, Santa Catarina, Brazil

  • Facility name not stated

    Campinas, São Paulo, Brazil

  • Facility name not stated

    Sao Jose de Rio Preto, São Paulo, Brazil

  • Facility name not stated

    Rio de Janeiro, Brazil

  • Facility name not stated

    São Paulo, Brazil

Colombia
  • Facility name not stated

    Cali, Valle del Cauca Department, Colombia

  • Facility name not stated

    Armenia, Colombia

  • Facility name not stated

    Barranquilla, Colombia

  • Facility name not stated

    Bogotá, Colombia

Estonia
  • Facility name not stated

    Kohtla-Järve, Estonia

  • Facility name not stated

    Tallinn, Estonia

  • Facility name not stated

    Tartu, Estonia

Georgia
  • Facility name not stated

    Tbilisi, Georgia

Germany
  • Facility name not stated

    Giessen, Hesse, Germany

  • Facility name not stated

    Lübeck, Schleswig-Holstein, Germany

Hungary
  • Facility name not stated

    Miskolc, Borsod-Abauj Zemplen county, Hungary

  • Facility name not stated

    Gyor, Budapest, Hungary

  • Facility name not stated

    Szentes, Csongrád megye, Hungary

  • Facility name not stated

    Sopron, Győr-Moson-Sopron, Hungary

  • Facility name not stated

    Salgótarján, Nógrád megye, Hungary

  • Facility name not stated

    Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

  • Facility name not stated

    Zalaegerszeg, Zala County, Hungary

  • Facility name not stated

    Budapest, Hungary

  • Facility name not stated

    Tatabánya, Hungary

Israel
  • Facility name not stated

    Kfar Saba, Sharon, Israel

  • Facility name not stated

    Petah Tikva, Teah Tiqwa, Israel

  • Facility name not stated

    Tel HaShomer, Tel Aviv, Israel

  • Facility name not stated

    Haifa, Israel

  • Facility name not stated

    Jerusalem, Israel

  • Facility name not stated

    Safed, Israel

Latvia
  • Facility name not stated

    Daugavpils, Latvia

  • Facility name not stated

    Liepāja, Latvia

  • Facility name not stated

    Riga, Latvia

  • Facility name not stated

    Valmiera, Latvia

  • Facility name not stated

    Ventspills, Latvia

Mexico
  • Facility name not stated

    Guadalajara, Jalisco, Mexico

  • Facility name not stated

    Chihuahua City, Mexico

  • Facility name not stated

    San Luis Potosí City, Mexico

36 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CXA-201Levofloxacin →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
20 Jun 2011
Primary completion
11 Aug 2013
Completion
4 Sept 2013
Last update posted
25 Oct 2018
Registered enrollment
558
Registry id
NCT01345929
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.