Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01445678
Recruitment Status : Completed
First Posted : October 4, 2011
Results First Posted : January 15, 2015
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Complicated Intra-abdominal Infection
Interventions Drug: CXA-201 and metronidazole
Drug: Meropenem
Enrollment 494
Recruitment Details  
Pre-assignment Details Two identical P3 protocols were initiated (NCT01445678 and NCT01445665) subsequently, Cubist and FDA agreed that integrated data from the 2 protocols could be analyzed and reported in a single Clinical Study Report. A total of 993 subjects were randomized to both arms, 493 to NCT5678 and 500 to NCT5665. Of these, 485 and 494 received treatment.
Arm/Group Title CXA-201 and Metronidazole as Treatment for cIAI Meropenem as Treatment for cIAI
Hide Arm/Group Description

CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days.

Of the 979 treated subjects in the integrated analysis set, 482 received CXA.

Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days Of the 979 treated subjects in the integrated analysis set, 497 received meropenem.
Period Title: Overall Study
Started 482 497
Completed 452 476
Not Completed 30 21
Reason Not Completed
Adverse Event             12             8
Lack of Efficacy             0             2
Lost to Follow-up             8             5
Protocol Violation             1             1
Withdrawal by Subject             9             5
Arm/Group Title CXA-201 and Metronidazole as Treatment for cIAI Meropenem as Treatment for cIAI Total
Hide Arm/Group Description CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days Total of all reporting groups
Overall Number of Baseline Participants 482 497 979
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 482 participants 497 participants 979 participants
50.6  (17.94) 50.5  (16.85) 50.5  (17.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 482 participants 497 participants 979 participants
Female
206
  42.7%
195
  39.2%
401
  41.0%
Male
276
  57.3%
302
  60.8%
578
  59.0%
1.Primary Outcome
Title The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population
Hide Description Clinical cure is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.
Time Frame TOC; 26-30 days after start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
MITT: Randomized patients, with baseline pathogen.
Arm/Group Title CXA-201 and Metronidazole as Treatment for cIAI Meropenem as Treatment for cIAI
Hide Arm/Group Description:
CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
Overall Number of Participants Analyzed 389 417
Measure Type: Number
Unit of Measure: percentage of subjects
83.0 87.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CXA-201 and Metronidazole as Treatment for cIAI, Meropenem as Treatment for cIAI
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-8.91 to 0.54
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population
Hide Description Success is eradication (absence of the baseline pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a subject who was assessed as a clinical cure) for each baseline pathogen
Time Frame TOC; 26-30 days after start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.
Arm/Group Title CXA-201 and Metronidazole as Treatment for cIAI Meropenem as Treatment for cIAI
Hide Arm/Group Description:
CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
Overall Number of Participants Analyzed 275 321
Measure Type: Number
Unit of Measure: percentage of subjects
94.2 94.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CXA-201 and Metronidazole as Treatment for cIAI, Meropenem as Treatment for cIAI
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-4.52 to 2.59
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Percentage of Subjects With Clinical Response at End of Therapy (EOT) Visit in the MITT Population
Hide Description Clinical response is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.
Time Frame EOT; Within 24 hours of last study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
MITT: Microbiological Intent-to-Treat: Randomized patients, with baseline pathogen.
Arm/Group Title CXA-201 and Metronidazole as Treatment for cIAI Meropenem as Treatment for cIAI
Hide Arm/Group Description:
CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
Overall Number of Participants Analyzed 389 417
Measure Type: Number
Unit of Measure: percentage of subjects
89.2 92.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CXA-201 and Metronidazole as Treatment for cIAI, Meropenem as Treatment for cIAI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -3.1
Confidence Interval (2-Sided) 95%
-7.23 to 0.89
Estimation Comments [Not Specified]
4.Secondary Outcome
Title The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population
Hide Description Clinical response is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.
Time Frame EOT; Within 24 hours of last study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.
Arm/Group Title CXA-201 and Metronidazole as Treatment for cIAI Meropenem as Treatment for cIAI
Hide Arm/Group Description:
CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
Overall Number of Participants Analyzed 275 321
Measure Type: Number
Unit of Measure: percentage of subjects
97.1 97.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CXA-201 and Metronidazole as Treatment for cIAI, Meropenem as Treatment for cIAI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-3.4 to 2.33
Estimation Comments [Not Specified]
5.Secondary Outcome
Title The Percentage of Subjects With Clinical Response at Long Term Follow-Up (LFU) in the MITT Population
Hide Description Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit.
Time Frame LFU; 38 to 45 days after first study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
MITT: Randomized patients, with baseline pathogen.
Arm/Group Title CXA-201 and Metronidazole as Treatment for cIAI Meropenem as Treatment for cIAI
Hide Arm/Group Description:
CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
Overall Number of Participants Analyzed 389 417
Measure Type: Number
Unit of Measure: percentage of subjects
82.5 86.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CXA-201 and Metronidazole as Treatment for cIAI, Meropenem as Treatment for cIAI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -4.1
Confidence Interval (2-Sided) 95%
-9.09 to 0.94
Estimation Comments [Not Specified]
6.Secondary Outcome
Title The Percentage of Subjects With Clinical Response at LFU Visit in the ME Population
Hide Description Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit
Time Frame LFU; 38 to 45 days after first study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.
Arm/Group Title CXA-201 and Metronidazole as Treatment for cIAI Meropenem as Treatment for cIAI
Hide Arm/Group Description:
CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
Overall Number of Participants Analyzed 258 304
Measure Type: Number
Unit of Measure: percentage of subjects
100 99.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CXA-201 and Metronidazole as Treatment for cIAI, Meropenem as Treatment for cIAI
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-0.88 to 2.37
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CXA-201 and Metronidazole as Treatment for cIAI Meropenem as Treatment for cIAI
Hide Arm/Group Description CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
All-Cause Mortality
CXA-201 and Metronidazole as Treatment for cIAI Meropenem as Treatment for cIAI
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CXA-201 and Metronidazole as Treatment for cIAI Meropenem as Treatment for cIAI
Affected / at Risk (%) Affected / at Risk (%)
Total   39/482 (8.09%)   36/497 (7.24%) 
Blood and lymphatic system disorders     
Thrombocytosis  1  1/482 (0.21%)  0/497 (0.00%) 
Cardiac disorders     
Cardiac failure  1  1/482 (0.21%)  1/497 (0.20%) 
Myocardial infarction  1  1/482 (0.21%)  1/497 (0.20%) 
Cardiogenic shock  1  1/482 (0.21%)  0/497 (0.00%) 
Cardiopulmonary failure  1  1/482 (0.21%)  0/497 (0.00%) 
Atrial fibrillation  1  0/482 (0.00%)  1/497 (0.20%) 
Cardiovascular insufficiency  1  0/482 (0.00%)  1/497 (0.20%) 
Endocrine disorders     
Goitre  1  0/482 (0.00%)  1/497 (0.20%) 
Gastrointestinal disorders     
Small intestinal obstruction  1  1/482 (0.21%)  2/497 (0.40%) 
Ileus  1  1/482 (0.21%)  1/497 (0.20%) 
Nausea  1  1/482 (0.21%)  1/497 (0.20%) 
Duodenal ulcer haemorrhage  1  1/482 (0.21%)  0/497 (0.00%) 
Enterocutaneous fistula  1  1/482 (0.21%)  0/497 (0.00%) 
Ileus paralytic  1  1/482 (0.21%)  0/497 (0.00%) 
Intestinal ischaemia  1  1/482 (0.21%)  0/497 (0.00%) 
Intestinal perforation  1  1/482 (0.21%)  0/497 (0.00%) 
Large intestine perforation  1  1/482 (0.21%)  0/497 (0.00%) 
Rectal perforation  1  1/482 (0.21%)  0/497 (0.00%) 
Small intestinal perforation  1  1/482 (0.21%)  0/497 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/482 (0.21%)  0/497 (0.00%) 
Vomiting  1  0/482 (0.00%)  1/497 (0.20%) 
General disorders     
Multi-organ failure  1  3/482 (0.62%)  0/497 (0.00%) 
Sudden death  1  2/482 (0.41%)  0/497 (0.00%) 
Non-cardiac chest pain  1  0/482 (0.00%)  1/497 (0.20%) 
Hepatobiliary disorders     
Portal vein thrombosis  1  1/482 (0.21%)  0/497 (0.00%) 
Bile duct stone  1  0/482 (0.00%)  2/497 (0.40%) 
Bilary fistula  1  0/482 (0.00%)  1/497 (0.20%) 
Perforation bile duct  1  0/482 (0.00%)  1/497 (0.20%) 
Infections and infestations     
Septic shock  1  3/482 (0.62%)  2/497 (0.40%) 
Abdominal abscess  1  2/482 (0.41%)  2/497 (0.40%) 
Pelvic abscess  1  1/482 (0.21%)  2/497 (0.40%) 
Clostridium difficile colitis  1  1/482 (0.21%)  1/497 (0.20%) 
Adominal infection  1  1/482 (0.21%)  0/497 (0.00%) 
Infectious peritonitis  1  1/482 (0.21%)  0/497 (0.00%) 
Lung infection pseudomonal  1  1/482 (0.21%)  0/497 (0.00%) 
Peridiverticular abscess  1  1/482 (0.21%)  0/497 (0.00%) 
Pneumonia staphylococcal  1  1/482 (0.21%)  0/497 (0.00%) 
Staphylococcal bacteraemia  1  1/482 (0.21%)  0/497 (0.00%) 
Urinary tract infection  1  1/482 (0.21%)  0/497 (0.00%) 
Liver abscess  1  0/482 (0.00%)  3/497 (0.60%) 
Pneumonia  1  0/482 (0.00%)  2/497 (0.40%) 
Subdiaphragmatic abscess  1  0/482 (0.00%)  2/497 (0.40%) 
Appendiceal abscess  1  0/482 (0.00%)  1/497 (0.20%) 
Device related infection  1  0/482 (0.00%)  1/497 (0.20%) 
Gallbladder abscess  1  0/482 (0.00%)  1/497 (0.20%) 
Graft infection  1  0/482 (0.00%)  1/497 (0.20%) 
Lobar pneumonia  1  0/482 (0.00%)  1/497 (0.20%) 
Pseudomembranous colitis  1  0/482 (0.00%)  1/497 (0.20%) 
Sepsis  1  0/482 (0.00%)  1/497 (0.20%) 
Injury, poisoning and procedural complications     
Wound evisceration  1  2/482 (0.41%)  0/497 (0.00%) 
Anastomotic leak  1  1/482 (0.21%)  1/497 (0.20%) 
Wound dehiscence  1  1/482 (0.21%)  1/497 (0.20%) 
Anaemia postoperative  1  1/482 (0.21%)  0/497 (0.00%) 
Suture rupture  1  1/482 (0.21%)  0/497 (0.00%) 
Abdominal wound dehiscence  1  0/482 (0.00%)  1/497 (0.20%) 
Pneumoconiosis  1  0/482 (0.00%)  1/497 (0.20%) 
Road traffic accident  1  0/482 (0.00%)  1/497 (0.20%) 
Investigations     
Hepatic enzyme increased  1  1/482 (0.21%)  0/497 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/482 (0.21%)  0/497 (0.00%) 
Dehydration  1  0/482 (0.00%)  1/497 (0.20%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  0/482 (0.00%)  1/497 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  1/482 (0.21%)  0/497 (0.00%) 
Nervous system disorders     
Ischaemic stroke  1  2/482 (0.41%)  0/497 (0.00%) 
Encephalopathy  1  0/482 (0.00%)  1/497 (0.20%) 
Transient ischaemic attach  1  0/482 (0.00%)  1/497 (0.20%) 
Renal and urinary disorders     
Renal failure  1  1/482 (0.21%)  0/497 (0.00%) 
Reproductive system and breast disorders     
Atrophic vulvovaginitis  1  1/482 (0.21%)  0/497 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  1/482 (0.21%)  2/497 (0.40%) 
Acute respiratory distress syndrome  1  1/482 (0.21%)  1/497 (0.20%) 
Respiratory distress  1  1/482 (0.21%)  1/497 (0.20%) 
Pleural effusion  1  1/482 (0.21%)  0/497 (0.00%) 
Pleurisy  1  1/482 (0.21%)  0/497 (0.00%) 
Pneumonia aspiration  1  0/482 (0.00%)  1/497 (0.20%) 
Pulmonary embolism  1  0/482 (0.00%)  1/497 (0.20%) 
Vascular disorders     
Deep vein thrombosis  1  1/482 (0.21%)  0/497 (0.00%) 
Pelvic venous thrombosis  1  1/482 (0.21%)  0/497 (0.00%) 
Shock haemorrhagic  1  1/482 (0.21%)  0/497 (0.00%) 
Circulatory collapse  1  0/482 (0.00%)  1/497 (0.20%) 
Intra-abdominal haemorrhage  1  0/482 (0.00%)  1/497 (0.20%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
CXA-201 and Metronidazole as Treatment for cIAI Meropenem as Treatment for cIAI
Affected / at Risk (%) Affected / at Risk (%)
Total   159/482 (32.99%)   138/497 (27.77%) 
Blood and lymphatic system disorders     
Anaemia  1  6/482 (1.24%)  4/497 (0.80%) 
Thrombocytosis  1  8/482 (1.66%)  5/497 (1.01%) 
Cardiac disorders     
Atrial fibrillation  1  6/482 (1.24%)  2/497 (0.40%) 
Tachycardia  1  7/482 (1.45%)  9/497 (1.81%) 
Gastrointestinal disorders     
Abdominal pain  1  6/482 (1.24%)  2/497 (0.40%) 
Constipation  1  9/482 (1.87%)  6/497 (1.21%) 
Diarrhoea  1  30/482 (6.22%)  25/497 (5.03%) 
Dyspepsia  1  2/482 (0.41%)  7/497 (1.41%) 
Nausea  1  37/482 (7.68%)  28/497 (5.63%) 
Vomiting  1  16/482 (3.32%)  19/497 (3.82%) 
General disorders     
Oedema peripheral  1  9/482 (1.87%)  4/497 (0.80%) 
Pyrexia  1  25/482 (5.19%)  20/497 (4.02%) 
Infections and infestations     
Pneumonia  1  5/482 (1.04%)  4/497 (0.80%) 
Injury, poisoning and procedural complications     
Anaemia postoperative  1  9/482 (1.87%)  8/497 (1.61%) 
Seroma  1  6/482 (1.24%)  7/497 (1.41%) 
Investigations     
Alanine aminotransferase increased  1  7/482 (1.45%)  5/497 (1.01%) 
Aspartate aminotransferase increased  1  5/482 (1.04%)  3/497 (0.60%) 
Gamma-glutamyltransferase increased  1  3/482 (0.62%)  5/497 (1.01%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  6/482 (1.24%)  3/497 (0.60%) 
Hypoalbuminaemia  1  7/482 (1.45%)  8/497 (1.61%) 
Hypocalcaemia  1  4/482 (0.83%)  9/497 (1.81%) 
Hypoglycaemia  1  2/482 (0.41%)  5/497 (1.01%) 
Hypokalaemia  1  14/482 (2.90%)  8/497 (1.61%) 
Hypomagnesaemia  1  6/482 (1.24%)  5/497 (1.01%) 
Hypophosphataemia  1  5/482 (1.04%)  3/497 (0.60%) 
Nervous system disorders     
Dizziness  1  4/482 (0.83%)  5/497 (1.01%) 
Headache  1  12/482 (2.49%)  9/497 (1.81%) 
Psychiatric disorders     
Anxiety  1  9/482 (1.87%)  7/497 (1.41%) 
Insomnia  1  17/482 (3.53%)  11/497 (2.21%) 
Renal and urinary disorders     
Dysuria  1  5/482 (1.04%)  2/497 (0.40%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/482 (0.21%)  6/497 (1.21%) 
Dyspnoea  1  4/482 (0.83%)  6/497 (1.21%) 
Pleural effusion  1  9/482 (1.87%)  7/497 (1.41%) 
Skin and subcutaneous tissue disorders     
Rash  1  4/482 (0.83%)  5/497 (1.01%) 
Vascular disorders     
Hypertension  1  9/482 (1.87%)  10/497 (2.01%) 
Hypotension  1  8/482 (1.66%)  4/497 (0.80%) 
Phlebitis  1  2/482 (0.41%)  5/497 (1.01%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Two identical P3 protocols were initiated (NCT01445678 and NCT01445665) subsequently, Cubist and FDA agreed that integrated data from the 2 protocols could be analyzed and reported in a single Clinical Study Report. These analyses are presented here.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Investigator(s) must undertake not to submit any part of the data from this protocol for publication without the prior consent of Cubist Pharmaceuticals, Inc.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Obi Umeh, Vice President Global Medical Sciences
Organization: Cubist Pharmaceuticals, Inc.
Phone: 781-860-8415
EMail: obiamiwe.umeh@cubist.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01445678     History of Changes
Obsolete Identifiers: NCT01445665
Other Study ID Numbers: 7625A-004
CXA-cIAI-10-09 ( Other Identifier: Cubist Study Number )
CXA-cIAI-10-08 ( Other Identifier: Cubist Study number for 7625A-003 )
First Submitted: September 26, 2011
First Posted: October 4, 2011
Results First Submitted: January 9, 2015
Results First Posted: January 15, 2015
Last Update Posted: November 16, 2018