Trial Outcomes & Findings for Acinetobacter Baumannii-related Osteomyelitis: Clinical and Epidemiological Characterization (NCT NCT03559530)

NCT ID: NCT03559530

Last Updated: 2021-05-18

Results Overview

Distribution of the clinical and epidemiological characteristics studied among the patients. Use of percentage and average for description.

• Recruitment status: COMPLETED
• Target enrollment: 262 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2021-05-18

Participant Flow

The initial database consisted of 262 patients. It was possible to collect data for 171 patients. Reasons for not including 91 patients: * non-location of medical records: 44; * culture results not considered for treatment: 29; * duplicate cases: 8; * other species of Acinetobacter: 7; * contamination / colonization: 3.

Participant milestones

Measure	Carbapenem Susceptible A. Baumannii 106 patients with osteomyelitis related to carbapenem-susceptible A. baumannii	XDR Acinetobacter Baumannii For this analysis, the 65 patients with XDR A. baumannii -related osteomyelitis, always resistant to carbapenems, treated with colistin or tigecycline were included.
Overall Study STARTED	197	65
Overall Study COMPLETED	106	65
Overall Study NOT COMPLETED	91	0

Reasons for withdrawal

Measure	Carbapenem Susceptible A. Baumannii 106 patients with osteomyelitis related to carbapenem-susceptible A. baumannii	XDR Acinetobacter Baumannii For this analysis, the 65 patients with XDR A. baumannii -related osteomyelitis, always resistant to carbapenems, treated with colistin or tigecycline were included.
Overall Study non-location of medical records	44	0
Overall Study culture results not considered for treat	29	0
Overall Study duplicate cases	8	0
Overall Study other species of Acinetobacte	7	0
Overall Study contamination / colonization	3	0

Baseline Characteristics

Acinetobacter Baumannii-related Osteomyelitis: Clinical and Epidemiological Characterization

Baseline characteristics by cohort

Measure	Patients n=171 Infections All patients with bone tissue culture positive for Acinetobacter baumannii submitted to surgical procedures to treat osteomyelitis
Age, Continuous	43.2 years n=171 Participants
Sex: Female, Male Female	37 Participants n=171 Participants
Sex: Female, Male Male	134 Participants n=171 Participants
Region of Enrollment Brazil	171 Participants n=171 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Described above.

Distribution of the clinical and epidemiological characteristics studied among the patients. Use of percentage and average for description.

Outcome measures

Measure	Patients n=171 Participants Patients with A. baumannii-related osteomyelitis
Description of the Clinical and Epidemiological Profile of Patients With Infection Remission	92 Participants
Description of the Clinical and Epidemiological Profile of Patients With Infection Relapse	26 Participants
Description of the Clinical and Epidemiological Profile of Patients With Infection Amputation	25 Participants
Description of the Clinical and Epidemiological Profile of Patients With Infection Lost follow-up	21 Participants
Description of the Clinical and Epidemiological Profile of Patients With Infection Death related to A. baumannii infection	6 Participants
Description of the Clinical and Epidemiological Profile of Patients With Infection Death not related to A. baumannii infection	1 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Percentage of patients with carbapenem-susceptible isolates of A. baumannii

A. baumannii isolates susceptible to the tested antimicrobials

Outcome measures

Measure	Patients n=171 Participants Patients with A. baumannii-related osteomyelitis
A. Baumannii Susceptibility Profile	57 Participants

Adverse Events

XDR A. Baumannii

Serious events: 36 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Measure	XDR A. Baumannii n=65 participants at risk Patients with microbiologically proven XDR A. baumannii-related osteomyelitis who received colistin or tigecycline for treatment
General disorders Renal impairment	41.5% 27/65 • Number of events 27 • 12 months Adverse events (AE) reported within 48 hours after initiation of treatment with colistin (CL) or tigecycline (TG) were analysed: renal impairment;liver alterations; nausea/vomiting; and skin rash. Any other AE that occurred during treatment, was classified as "other event". AE were analyzed only for patients who received CL or TG. For this reason, there was no assessment of the occurrence of AE in patients in the "Carbapenem Susceptible A. baumannii" group, as they received neither CL nor TG.
Hepatobiliary disorders Liver abnormalities	3.1% 2/65 • Number of events 2 • 12 months Adverse events (AE) reported within 48 hours after initiation of treatment with colistin (CL) or tigecycline (TG) were analysed: renal impairment;liver alterations; nausea/vomiting; and skin rash. Any other AE that occurred during treatment, was classified as "other event". AE were analyzed only for patients who received CL or TG. For this reason, there was no assessment of the occurrence of AE in patients in the "Carbapenem Susceptible A. baumannii" group, as they received neither CL nor TG.
Gastrointestinal disorders Nausea	6.2% 4/65 • Number of events 4 • 12 months Adverse events (AE) reported within 48 hours after initiation of treatment with colistin (CL) or tigecycline (TG) were analysed: renal impairment;liver alterations; nausea/vomiting; and skin rash. Any other AE that occurred during treatment, was classified as "other event". AE were analyzed only for patients who received CL or TG. For this reason, there was no assessment of the occurrence of AE in patients in the "Carbapenem Susceptible A. baumannii" group, as they received neither CL nor TG.
Immune system disorders Skin rash	1.5% 1/65 • Number of events 1 • 12 months Adverse events (AE) reported within 48 hours after initiation of treatment with colistin (CL) or tigecycline (TG) were analysed: renal impairment;liver alterations; nausea/vomiting; and skin rash. Any other AE that occurred during treatment, was classified as "other event". AE were analyzed only for patients who received CL or TG. For this reason, there was no assessment of the occurrence of AE in patients in the "Carbapenem Susceptible A. baumannii" group, as they received neither CL nor TG.
Investigations Other	10.8% 7/65 • Number of events 7 • 12 months Adverse events (AE) reported within 48 hours after initiation of treatment with colistin (CL) or tigecycline (TG) were analysed: renal impairment;liver alterations; nausea/vomiting; and skin rash. Any other AE that occurred during treatment, was classified as "other event". AE were analyzed only for patients who received CL or TG. For this reason, there was no assessment of the occurrence of AE in patients in the "Carbapenem Susceptible A. baumannii" group, as they received neither CL nor TG.

Other adverse events

Adverse event data not reported

Additional Information

Dr Priscila Rosalba Domingos de Oliveira

Unversidade de Sao Paulo

Phone: 551126616900

Email: priscila.rosalba@hc.fm.usp.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place