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Trial record 2 of 232 for:    clindamycin

Clindamycin Once a Day in Septic Abortion (CLINDA-PRO)

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ClinicalTrials.gov Identifier: NCT02309346
Recruitment Status : Recruiting
First Posted : December 5, 2014
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:

Septic abortion is a serious condition. Women with septic abortion are treated with clindamycin plus gentamicin using divided doses, i.e., thrice a day.

The objective of this study is to compare the rates of cure between once or thrice a day use of clindamycin with gentamicin in cases of septic abortion.


Condition or disease Intervention/treatment Phase
Septic Abortion Drug: Clindamycin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Between Clindamycin Once and Thrice a Day in Septic Abortion.
Study Start Date : December 31, 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: clindamycin once a day
Clindamycin 2700mg+gentamicin 240mg+ 250ml sterile saline solution i.v. once a day until clinical improvement
Drug: Clindamycin
Use of Clindamycin 2700mg+gentamicin 240mg+ 250ml sterile saline solution i.v. once a day or Gentamcin 240mg i.v once a day, plus clindamycin 900mg i.v. 8/8 h diluted in 250ml of sterile saline solution

Active Comparator: clindamycin thrice a day
Gentamcin 240mg i.v once a day, plus clindamycin 900mg i.v. 8/8 h diluted in 250ml of sterile saline solution
Drug: Clindamycin
Use of Clindamycin 2700mg+gentamicin 240mg+ 250ml sterile saline solution i.v. once a day or Gentamcin 240mg i.v once a day, plus clindamycin 900mg i.v. 8/8 h diluted in 250ml of sterile saline solution




Primary Outcome Measures :
  1. Cure (Clinical improvement defined as reduce of pain, bleeding and no fever for 48h) [ Time Frame: 72 hours ]
    Clinical improvement defined as reduce of pain, bleeding and no fever for 48h Treatment failure will be considered as persistence of fever (≥37.8ºC) during hospital admission, worsening of abdominal pain, persistent vaginal bleeding, need for exchange clindamycin due to treatment failure, or the need to add other antibiotics, either intravenously or orally.


Secondary Outcome Measures :
  1. Complications (Return to the hospital for admission related to the evacuation procedure within 7 days) [ Time Frame: 7 days ]
    Return to the hospital for admission related to the evacuation procedure within 7 days



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Ages Eligible for Study:   13 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with clinical diagnosis of septic abortion

Exclusion Criteria:

  • Refuse to participate in the study
  • Use of antibiotics with 1 week prior randomization
  • Known allergy to clindamycin or gentamcin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309346


Contacts
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Contact: Daniel M da Silva, Phar +555133597542 danielmsilva@hcpa.edu.br
Contact: Ernesto P Guedes neto, MD, PhD +555132211455 epgneto@gmail.com

Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
Contact: Ricardo F Savaris, MD, PhD    55 51 33598405    rsavaris@hcpa.edu.br   
Principal Investigator: Ricardo F Savaris, MD, PhD         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Ricardo F Savaris, MD, PhD Federal University of Rio Grande do Sul

Publications of Results:
Other Publications:

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02309346     History of Changes
Other Study ID Numbers: 14-0328
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
clindamycin
septic abortion
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Abortion, Septic
Pregnancy Complications, Infectious
Infection
Abortion, Spontaneous
Pregnancy Complications
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action