Trial Outcomes & Findings for Clindamycin Once a Day in Septic Abortion (NCT NCT02309346)

Results Overview

Clinical improvement was defined by meeting all of the following criteria for a minimum of 48 consecutive hours: Reduction in pain, Reduction in vaginal bleeding, Absence of fever (afebrile)" Treatment failure was defined as the occurrence of any of the following events during hospital admission: Persistence of fever (temperature ≥37.8ºC), Worsening of abdominal pain, Persistent vaginal bleeding, Necessity to change the primary antibiotic (clindamycin), Addition of any other intravenous or oral antibiotics. For the purposes of analysis, patients who were lost to follow-up were classified as treatment failures.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

202 participants

Primary outcome timeframe

cure at 72 hours

Results posted on

2025-12-05

Participant Flow

The study was conducted between December 17, 2014, and December 31, 2023, at the gynecological emergency unit of Hospital de Clínicas de Porto Alegre, RS, Brazil.

Eligible patients will be invited to participate upon admission to the HCPA. After they read and sign the informed consent, patients will be randomized. Patients will be excluded from the study if they do not wish to participate, have used antimicrobials within one week of admission, or are allergic to clindamycin or gentamicin

Participant milestones

Participant milestones
Measure	clindamycin once a day The intervention group received a single daily-dose regimen. At hour 0, participants were administered an infusion containing 240 mg of gentamicin and a total daily dose of 2700 mg of clindamycin. At hours 8 and 16, they received placebo infusions containing only the 0.9% saline solution.	clindamycin thrice a day The comparator group received the standard multiple-dose regimen. At hour 0, participants were administered an infusion containing 240 mg of gentamicin and 900 mg of clindamycin. At hours 8 and 16, they received subsequent infusions each containing 900 mg of clindamycin diluted in 250 ml bags of 0.9% saline solution
Overall Study STARTED	101	101
Overall Study First enrolment	1	1
Overall Study COMPLETED	101	101
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clindamycin Once a Day in Septic Abortion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clindamycin Once a Day n=101 Participants Clindamycin 2700mg+gentamycin 240mg+ 250ml sterile saline solution i.v. once a day until clinical improvement	Clindamycin Thrice a Day n=101 Participants Gentamycin 240mg i.v. once a day + plus clindamycin 900mg diluted in 250ml of sterile saline solution thrice a day.	Total n=202 Participants Total of all reporting groups
Age, Continuous	27.78 years STANDARD_DEVIATION 7.72 • n=37 Participants	29.11 years STANDARD_DEVIATION 7.72 • n=37 Participants	28.44 years STANDARD_DEVIATION 7.46 • n=74 Participants
Sex: Female, Male Female	101 Participants n=37 Participants	101 Participants n=37 Participants	202 Participants n=74 Participants
Sex: Female, Male Male	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	71 Participants n=37 Participants	79 Participants n=37 Participants	150 Participants n=74 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=37 Participants	22 Participants n=37 Participants	52 Participants n=74 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Gestational age	10.47 weeks STANDARD_DEVIATION 4.09 • n=37 Participants	10.74 weeks STANDARD_DEVIATION 4.09 • n=37 Participants	10.6 weeks STANDARD_DEVIATION 4.15 • n=74 Participants

PRIMARY outcome

Timeframe: cure at 72 hours

Population: no difference between values here and the numbers of participants, Intention To Treat

Clinical improvement was defined by meeting all of the following criteria for a minimum of 48 consecutive hours: Reduction in pain, Reduction in vaginal bleeding, Absence of fever (afebrile)" Treatment failure was defined as the occurrence of any of the following events during hospital admission: Persistence of fever (temperature ≥37.8ºC), Worsening of abdominal pain, Persistent vaginal bleeding, Necessity to change the primary antibiotic (clindamycin), Addition of any other intravenous or oral antibiotics. For the purposes of analysis, patients who were lost to follow-up were classified as treatment failures.

Outcome measures

Outcome measures
Measure	clindamycin once a day n=101 Participants Clindamycin 2700mg+gentamicin 240mg+ 250ml sterile saline solution i.v. once a day until clinical improvement	clindamycin thrice a day n=101 Participants Gentamycin 240mg i.v once a day, plus clindamycin 900mg i.v. 8/8 h diluted in 250ml of sterile saline solution
Cure (Clinical Improvement Defined as Reduce of Pain, Bleeding and no Fever for 48h)	94.06 percentage of cure Interval 87.64 to 97.25	86.14 percentage of cure Interval 78.07 to 91.56

SECONDARY outcome

Timeframe: 7 days

Number of patients who required hospital readmission for a repeat uterine curettage within 7 days of initial hospital discharge. Data was collected from patient's electronic medical records.

Outcome measures

Outcome measures
Measure	clindamycin once a day n=101 Participants Clindamycin 2700mg+gentamicin 240mg+ 250ml sterile saline solution i.v. once a day until clinical improvement	clindamycin thrice a day n=101 Participants Gentamycin 240mg i.v once a day, plus clindamycin 900mg i.v. 8/8 h diluted in 250ml of sterile saline solution
Hospital Readmission Within 7 Days	0 Participants	0 Participants

Adverse Events

clindamycin once a day

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

clindamycin thrice a day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	clindamycin once a day n=101 participants at risk Clindamycin 2700mg+gentamycin 240mg+ 250ml sterile saline solution i.v. once a day until clinical improvement	clindamycin thrice a day n=101 participants at risk Gentamycin 240mg i.v once a day, plus clindamycin 900mg i.v. 8/8 h diluted in 250ml of sterile saline solution
Skin and subcutaneous tissue disorders cutaneous rash	0.99% 1/101 • Number of events 1 • follow up within 7 days	0.00% 0/101 • follow up within 7 days
Gastrointestinal disorders diarrhea	3.0% 3/101 • Number of events 3 • follow up within 7 days	0.00% 0/101 • follow up within 7 days

Additional Information

Ricardo Francalacci Savaris

Hospital de Clínicas de Porto Alegre

Phone: +55 51 33596042

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place