Trial Outcomes & Findings for Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections. (NCT NCT02202135)

NCT ID: NCT02202135

Last Updated: 2017-09-06

Results Overview

Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention \>48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis \>=8 days after the first dose.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

4 participants

Primary outcome timeframe

7 to 20 days after last dose of study drug

Results posted on

2017-09-06

Participant Flow

Overall, 4 patients were enrolled from 2 centres in 1 regions in this study. The first patient was enrolled on 15 September 2014 and the last patient last visit was on 02 January 2015.

Participant milestones

Participant milestones
Measure	Ceftaroline Ceftaroline fosamil 600 mg 120 min
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ceftaroline n=4 Participants Ceftaroline fosamil 600 mg 120 min
Age, Continuous	80.25 years STANDARD_DEVIATION 4.875 • n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	4 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 7 to 20 days after last dose of study drug

Population: Randomized

Outcome measures

Outcome measures
Measure	Ceftaroline n=4 Participants Ceftaroline fosamil 600 mg 120 min
Clinical Response at TOC Clinical cure	3 Participant
Clinical Response at TOC Clinical failure	0 Participant
Clinical Response at TOC Indeterminate	1 Participant

Adverse Events

Ceftaroline

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ceftaroline n=4 participants at risk Ceftaroline fosamil 600 mg 120 min
Infections and infestations Pneumonia	25.0% 1/4 • Number of events 1 • Adverse events were collected from time of the first dose of study drug up to TOC visit (8 to 15 days after the last dose). Serious AEs were collected from time of signature of informed consent up to the LFU visit (21 to 35 days after the last dose).

Other adverse events

Other adverse events
Measure	Ceftaroline n=4 participants at risk Ceftaroline fosamil 600 mg 120 min
Skin and subcutaneous tissue disorders Rash generalised	25.0% 1/4 • Number of events 1 • Adverse events were collected from time of the first dose of study drug up to TOC visit (8 to 15 days after the last dose). Serious AEs were collected from time of signature of informed consent up to the LFU visit (21 to 35 days after the last dose).
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • Number of events 1 • Adverse events were collected from time of the first dose of study drug up to TOC visit (8 to 15 days after the last dose). Serious AEs were collected from time of signature of informed consent up to the LFU visit (21 to 35 days after the last dose).
Infections and infestations Urinary tract	25.0% 1/4 • Number of events 1 • Adverse events were collected from time of the first dose of study drug up to TOC visit (8 to 15 days after the last dose). Serious AEs were collected from time of signature of informed consent up to the LFU visit (21 to 35 days after the last dose).
Cardiac disorders Cardiac failure	25.0% 1/4 • Number of events 1 • Adverse events were collected from time of the first dose of study drug up to TOC visit (8 to 15 days after the last dose). Serious AEs were collected from time of signature of informed consent up to the LFU visit (21 to 35 days after the last dose).
Infections and infestations Fungal skin infection	25.0% 1/4 • Number of events 1 • Adverse events were collected from time of the first dose of study drug up to TOC visit (8 to 15 days after the last dose). Serious AEs were collected from time of signature of informed consent up to the LFU visit (21 to 35 days after the last dose).
Skin and subcutaneous tissue disorders Dermatitis contact	25.0% 1/4 • Number of events 1 • Adverse events were collected from time of the first dose of study drug up to TOC visit (8 to 15 days after the last dose). Serious AEs were collected from time of signature of informed consent up to the LFU visit (21 to 35 days after the last dose).
Skin and subcutaneous tissue disorders Dermatitis allergic	25.0% 1/4 • Number of events 1 • Adverse events were collected from time of the first dose of study drug up to TOC visit (8 to 15 days after the last dose). Serious AEs were collected from time of signature of informed consent up to the LFU visit (21 to 35 days after the last dose).
Psychiatric disorders Anxiety	25.0% 1/4 • Number of events 1 • Adverse events were collected from time of the first dose of study drug up to TOC visit (8 to 15 days after the last dose). Serious AEs were collected from time of signature of informed consent up to the LFU visit (21 to 35 days after the last dose).

Additional Information

Yunxia Lu

AstraZeneca-PPD

Phone: 910-558-4197

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees not to use such Confidential study information and not to disclose them to any other third parties, except that the undersigned shall not be prevented from using or disclosing information: (a) which by written records was previously known; (b) which is now public knowledge, (c) which is lawfully obtained by the undersigned from sources who have a lawful right to disclose such information.
Publication restrictions are in place

Restriction type: OTHER