| CTRI Number |
CTRI/2018/03/012682 [Registered on: 20/03/2018] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing long and short duration antibiotics for abdominal infections |
|
Scientific Title of Study
|
Comparison of short course antimicrobial therapy vs. conventional antimicrobial therapy in patients with complicated intra-abdominal infections- A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinodhini P |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Post-Graduate Medical Education and Research |
| Address |
Department of Surgery,Jawaharlal Institute of Post-Graduate Medical Education and Research, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
vino91292@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Vikram Kate |
| Designation |
Professor (Senior Scale) |
| Affiliation |
Jawaharlal Institute of Post-Graduate Medical Education and Research |
| Address |
Department of Surgery, Jawaharlal Institute of Post-Graduate Medical Education and Research, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
drvikramkate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Vikram Kate |
| Designation |
Professor (Senior Scale) |
| Affiliation |
Jawaharlal Institute of Post-Graduate Medical Education and Research |
| Address |
Department of Surgery, Jawaharlal Institute of Post-Graduate Medical Education and Research, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
drvikramkate@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Post-Graduate Medical Education and Research, Dhanvantri Nagar, Puducherry -605006, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of PostGraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Post-Graduate Medical Education and Research, Dhanvantri Nagar, Puducherry -605006, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinodhini P |
Jawaharlal Institute of Post Graduate Medical Education and Research |
Department of Surgery,
Old in patient block,
Second Floor and Third floor, Wards
31,34,36,37 and Surgery ICU
Pondicherry
PONDICHERRY |
8870366952
vino91292@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Long course anti-microbial therpay |
Anti-microbial as per surgical unit protocol.
Administration route and dosage of the anti-microbial will be as per CDC guidelines
Duration : 7-10 days
|
| Intervention |
Short course anti-microbial therapy |
Anti-microbial as per surgical unit protocol.
Administration route and dosage of the anti-microbial will be as per CDC guidelines
Duration : 5-7 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients of complicated intra-abdominal infections (CIAI) who undergo surgical intervention to achieve adequate source control + one or more of the following:
1. Temperature ≤36C or ≥ 38 C
2. WBC count≤4000 or ≥ 11,000/mm3
3. Gastrointestinal dysfunction due to peritonitis, precluding intake of more than half their normal diet (as an indicator of an ileus) |
|
| ExclusionCriteria |
| Details |
1. Non-perforate, non-gangrenous appendicitis or cholecystitis
2. Infected necrotizing pancreatitis.
3. Primary spontaneous bacterial peritonitis
4. Infection associated with indwelling peritoneal dialysis catheter
5.High likelihood of death within 72h[ Patients in the post operative period who require two ionotropes to maintain hemodynamic stability and are above the age of 65]
6.Pregnancy
7.Concurrent infection requiring more than five days of antimicrobial therapy or various antimicrobial regimen.
8.Patients undergoing planned re-laparotomy
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Surgical-site infection,
2. Recurrent intra-abdominal infection requiring either surgical or percutaneous re-intervention
3. 30 day mortality
between the groups of patients with complicated intra-abdominal infection (CIAI), receiving conventional antimicrobial therapy and short course antimicrobial therapy
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the rates of individual primary end point components between the two groups |
30 days |
| To compare the time to the occurrence of the composite primary outcome between the two groups |
30 days |
| To compare the duration of antimicrobial therapy for index infection between the two groups |
30 days |
| To compare the Antimicrobial-free days at 30 days between the two groups. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2018 |
| Date of Study Completion (India) |
31/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Title: Comparison of short course antimicrobial therapy vs. conventional antimicrobial therapy in patients with complicated intra-abdominal infections – A randomized control trial Rationale: Although published guidelines are recommending benefits of shorter duration antimicrobial therapy in patients with CIAI following source control, due to limited studies , the appropriate duration of therapy remains unclear (1). Short course antimicrobial therapy has an advantage over conventional antimicrobial therapy in terms of reduced hospital stay, less incidence of antimicrobial resistance, increased compliance to the therapy and decreases the expenditure on antibiotics. Hypothesis: Whether the efficacy of short course antibiotics is comparable with conventional anti-microbial therapy in complicated intra-abdominal infections. Expected outcome and application:The short course antimicrobial therapy if found to be as efficacious and safe as conventional long-term antimicrobial therapy, will help in cost savings in terms of expenditure for prolonged antimicrobial therapy and shortened length of hospitalization without an increase in the postoperative morbidity. This will also likely improve the patients’ compliance to therapy and reduce the risk of emerging microbial resistance.
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