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Clinical Trials/EUCTR2022-003217-11-NL
EUCTR2022-003217-11-NL
Active, not recruiting
Phase 1

Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple procedure (SPARROW): a multicenter, randomized controlled trial - SPARROW trial

eiden University Medical Center0 sites304 target enrollmentFebruary 24, 2023
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ConditionsPancreatic head malignancyMedDRA version: 21.0Level: LLTClassification code 10033614Term: Pancreatic carcinoma resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10026319Term: Malignant neoplasm of pancreatic ductSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 27.0Level: LLTClassification code 10008597Term: Cholangiocarcinoma resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsCefuroximeMetronidazole

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Pancreatic head malignancy
Sponsor
eiden University Medical Center
Enrollment
304
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 24, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
eiden University Medical Center

Eligibility Criteria

Inclusion Criteria

  • •Patients undergoing elective pancreatoduodenectomy with a high risk for contaminated bile defined as patients with preoperative biliary drainage or an ampullary malignancy.
  • •Age \>18 years
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 104
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 200

Exclusion Criteria

  • •Contraindication for the study antibiotics (e.g. allergy or intolerance)
  • •Preoperative planned therapeutic antibiotic treatment (i.e. for cholangitis or liver abscesses)

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple procedure (SPARROW): a multicenter, randomized controlled trialPancreatic cancer100179901001981510014713
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(SPARROW) Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple’s procedure (SPARROW): a multicenter, randomized controlled trialPancreatoduodenectomy with a high risk for contaminated bileTherapeutic area: Diseases [C] - Neoplasms [C04]Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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comparison of antibiotics in elective caesarean sectioHealth Condition 1: O860- Infection of obstetric surgical woundHealth Condition 2: O861- Other infection of genital tract following deliveryHealth Condition 3: O868- Other specified puerperal infectionsHealth Condition 4: O864- Pyrexia of unknown origin following deliveryHealth Condition 5: O862- Urinary tract infection followingdelivery
CTRI/2024/08/072337Dr NEHA SINGH