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Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis

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ClinicalTrials.gov Identifier: NCT02424734
Recruitment Status : Terminated (Study was terminated on 22Dec2017 due to slow enrollment; there were no safety or efficacy concerns.)
First Posted : April 23, 2015
Results First Posted : July 17, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Condition Late-onset Sepsis
Interventions Drug: Ceftaroline Fosamil
Drug: Ampicillin
Drug: Aminoglycoside
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
Hide Arm/Group Description Young infants aged greater than (>) 28 days to less than (<) 60 days, received ceftaroline fosamil infusion, intravenously (IV) at a dose of 4 milligrams per kilogram (mg/kg) or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. Term Neonates (defined as gestational age greater than or equal to [>=] 37 weeks) aged 7 to less than equal to (<=28) days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
Period Title: Overall Study
Started 4 5 2
Treated 4 5 2
Completed 2 3 2
Not Completed 2 2 0
Reason Not Completed
Treatment stopped to be discharged home             2             2             0
Arm/Group Title Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates Total
Hide Arm/Group Description Young infants aged >28 days to <60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. Term Neonates (defined as gestational age >= 37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. Total of all reporting groups
Overall Number of Baseline Participants 4 5 2 11
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) analysis set consisted of all enrolled participants for whom informed consent form was signed.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 4 participants 5 participants 2 participants 11 participants
48.0  (4.69) 22.0  (3.81) 15.5  (4.95) 30.3  (14.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 2 participants 11 participants
Female
3
  75.0%
1
  20.0%
1
  50.0%
5
  45.5%
Male
1
  25.0%
4
  80.0%
1
  50.0%
6
  54.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 2 participants 11 participants
Hispanic or Latino
0
   0.0%
1
  20.0%
0
   0.0%
1
   9.1%
Not Hispanic or Latino
4
 100.0%
4
  80.0%
2
 100.0%
10
  90.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 2 participants 11 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  25.0%
0
   0.0%
0
   0.0%
1
   9.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
3
  75.0%
5
 100.0%
2
 100.0%
10
  90.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to study follow-up (SFU) visit (28 to 35 days after last dose of study treatment) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Time Frame Baseline up to SFU visit (up to a maximum study duration of 49 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set consisted of all enrolled participants for whom informed consent form was signed and received any amount of ceftaroline fosamil.
Arm/Group Title Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
Hide Arm/Group Description:
Young infants aged >28 days to <60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
Term Neonates (defined as gestational age >= 37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
Overall Number of Participants Analyzed 4 5 2
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
1
  25.0%
3
  60.0%
1
  50.0%
SAEs
0
   0.0%
0
   0.0%
1
  50.0%
Discontinuations Due to AEs
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Plasma Concentration of Ceftaroline Fosamil
Hide Description Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above limit of quantification (LOQ). LOQ was 50 nanogram per milliliter (ng/mL).
Time Frame At the end of infusion (EOI)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.
Arm/Group Title Ceftaroline Fosamil: All Participants
Hide Arm/Group Description:
All participants who received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: ng/mL
Participant 1 67.7
Participant 2 63.7
Participant 3 74.5
3.Secondary Outcome
Title Plasma Concentration of Ceftaroline
Hide Description Ceftaroline fosamil was the prodrug of ceftaroline. Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL
Time Frame At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.
Arm/Group Title Ceftaroline Fosamil: All Participants
Hide Arm/Group Description:
All participants who received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: ng/mL
Participant 1: 3 to 4 hrs EOI 3420
Participant 2: At EOI 12400
Participant 2: At 3 to 4 hours after EOI 4280
Participant 3: At EOI 7890
Participant 3: At 3 to 4 hours after EOI 1760
Participant 4: At 15 minutes to 2 hours after EOI 9440
Participant 4: At 5 to 7 hours after EOI 1800
Participant 5: At EOI 9410
Participant 6: 15 minutes to 2 hours after EOI 4370
Participant 7: At 15 minutes to 2 hours after EOI 5550
Participant 7: At 5 to 7 hours after EOI 1870
Participant 8:At 15 minutes to 2 hours after EOI 2240
Participant 8: At 5 to 7 hours after EOI 4770
Participant 9: At 15 minutes to 2 hours after EOI 4750
Participant 9: At 5 to 7 hours after EOI 1700
Participant 10: At EOI 9700
Participant 10: At 3 to 4 hours after EOI 3550
Participant 11: At 15 minutes to 2 hours after EOI 4760
Participant 11: At 5 to 7 hours after EOI 2440
4.Secondary Outcome
Title Plasma Concentration of Ceftaroline M-1
Hide Description Ceftaroline M-1 was the inactive metabolite of ceftaroline. Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL
Time Frame At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set will include all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.
Arm/Group Title Ceftaroline Fosamil: All Participants
Hide Arm/Group Description:
All participants who received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: ng/mL
Participant 1: At 3 to 4 hours after EOI 729
Participant 2: At EOI 678
Participant 2: At 3 to 4 hours after EOI 749
Participant 3: At EOI 950
Participant 3: At 3 to 4 hours after EOI 559
Participant 4: At 15 minutes to 2 hours after EOI 970
Participant 4: At 5 to 7 hours after EOI 642
Participant 5: At EOI 850
Participant 6: At 15 minutes to 2 hours after EOI 832
Participant 7: At 15 minutes to 2 hours after EOI 728
Participant 7: At 5 to 7 hours after EOI 634
Participant 8: At 15 minutes to 2 hours after EOI 630
Participant 8: At 5 to 7 hours after EOI 785
Participant 9: At 15 minutes to 2 hours after EOI 592
Participant 9: At 5 to 7 hours after EOI 461
Participant 10: At EOI 575
Participant 10: At 3 to 4 hours after EOI 648
Participant 11: At 15 minutes to 2 hours after EOI 671
Participant 11: At 5 to 7 hours after EOI 646
5.Secondary Outcome
Title Percentage of Participants With Favorable Clinical Response
Hide Description Clinical response was assessed by the investigator as Cure, Failure or Indeterminate at End of treatment (EOT) and Test of Cure (TOC). Favorable clinical response was defined as clinical response of Cure (defined as resolution of all acute signs and symptoms of Late-onset sepsis [LOS] or improvement to such an extent that no further antibacterial therapy is required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after the last dose of study therapy.
Time Frame EOT visit (up to Day 15), TOC visit (up to Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT analysis set: participants who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis (diagnosis of sepsis within 36 hours before enrolment [defined as presence of >=2 clinical criteria, >=1 laboratory criteria in presence of or as a result of suspected /proven bacterial infection that requires IV therapy]).
Arm/Group Title Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
Hide Arm/Group Description:
Young infants aged >28 days to <60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
Term Neonates (defined as gestational age >= 37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
Overall Number of Participants Analyzed 4 3 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
At EOT visit
50.0
(12.3 to 87.7)
33.3
(3.9 to 82.3)
100
(14.7 to 100)
At TOC visit
50.0
(12.3 to 87.7)
33.3
(3.9 to 82.3)
100
(14.7 to 100)
6.Secondary Outcome
Title Percentage of Participants With Favorable Microbiological Response
Hide Description Microbiological response was determining programmatically and assessed at the participants level at EOT and TOC. Microbiological response was defined as Favorable (Eradication or Presumed Eradication), Unfavorable (Persistence or Presumed Persistence) or Indeterminate (participant's clinical response is Indeterminate and no microbiological culture data is available). Eradication defined as absence of the original baseline pathogen from the source specimen; presumed eradication was defined when source specimen was not available to culture and the participant was assessed as a clinical cure (resolution of all acute signs and symptoms of LOS or improvement to such an extent that no further antibacterial therapy was required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after last dose of study drug.
Time Frame EOT visit (up to Day 15), TOC visit (up to Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT analysis set: participants who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis (diagnosis of sepsis within 36 hours before enrolment [defined as presence of >=2 clinical criteria, >=1 laboratory criteria in presence of or as a result of suspected /proven bacterial infection that requires IV therapy).
Arm/Group Title Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
Hide Arm/Group Description:
Young infants aged >28 days to <60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
Term Neonates (defined as gestational age >= 37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
Overall Number of Participants Analyzed 4 3 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
At EOT visit
50.0
(12.3 to 87.7)
66.7
(17.7 to 96.1)
100
(14.7 to 100)
At TOC visit
25.0
(2.8 to 71.6)
33.3
(3.9 to 82.3)
100
(14.7 to 100)
Time Frame Baseline up to SFU visit (up to a maximum study duration of 49 days)
Adverse Event Reporting Description Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
 
Arm/Group Title Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
Hide Arm/Group Description Young infants aged >28 days to <60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. Term Neonates (defined as gestational age >= 37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator. Preterm neonates (defined as gestational age >=34 weeks to <37 weeks) aged 7 to <=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
All-Cause Mortality
Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%)   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%)   1/2 (50.00%) 
Infections and infestations       
Salmonellosis * 1  0/4 (0.00%)  0/5 (0.00%)  1/2 (50.00%) 
1
Term from vocabulary, MedDRA v20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ceftaroline Fosamil: Young Infants Ceftaroline Fosamil: Term Neonates Ceftaroline Fosamil: Preterm Neonates
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)   3/5 (60.00%)   1/2 (50.00%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/4 (0.00%)  0/5 (0.00%)  1/2 (50.00%) 
Gastrointestinal disorders       
Diarrhoea * 1  1/4 (25.00%)  1/5 (20.00%)  0/2 (0.00%) 
Infections and infestations       
Oral candidiasis * 1  0/4 (0.00%)  1/5 (20.00%)  0/2 (0.00%) 
Otitis externa * 1  0/4 (0.00%)  0/5 (0.00%)  1/2 (50.00%) 
Nervous system disorders       
Cerebral cyst * 1  0/4 (0.00%)  1/5 (20.00%)  0/2 (0.00%) 
Renal and urinary disorders       
Pyelocaliectasis * 1  1/4 (25.00%)  0/5 (0.00%)  0/2 (0.00%) 
Rhinitis * 1  0/4 (0.00%)  0/5 (0.00%)  1/2 (50.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis * 1  0/4 (0.00%)  1/5 (20.00%)  0/2 (0.00%) 
1
Term from vocabulary, MedDRA v20.0
*
Indicates events were collected by non-systematic assessment
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02424734     History of Changes
Other Study ID Numbers: D3720C00009
C2661002 ( Other Identifier: Alias Study Number )
2014-003243-34 ( EudraCT Number )
First Submitted: February 23, 2015
First Posted: April 23, 2015
Results First Submitted: June 19, 2018
Results First Posted: July 17, 2018
Last Update Posted: September 13, 2018