NCT02089568

Brief Summary

The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney donation surgery prevent infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

4.1 years

First QC Date

March 14, 2014

Last Update Submit

August 18, 2016

Conditions

Infection

Keywords

Living donationAntibioticsLaparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Rate of infection after surgery

    24 months

Secondary Outcomes (7)

  • Ultrasonic evidence of wound healing

    24 months

  • Length of hospital stay

    24 months

  • Readmission rates

    24 months

  • Antibiotic associated side effects

    24 months

  • Return to work and normal activities

    24 months

  • +2 more secondary outcomes

Study Arms (2)

Drug: co-amoxiclav

EXPERIMENTAL

experimental

Drug: Co-Amoxiclav

Control

PLACEBO COMPARATOR

comparator

Drug: Normal Saline

Interventions

Co-AmoxiclavDRUG

Will receive 1.2g co-amoxiclav at induction

Also known as: Augmentin
Drug: co-amoxiclav
Normal SalineDRUG

Placebo - 0.9% saline

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included.
  • Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is our normal practice.
  • Women of child-bearing age taking adequate contraception will be included.

You may not qualify if:

  • Patients with a known allergy to penicillin or other antibiotics.
  • Patients with MRSA colonisation.
  • Participation in another investigational study within the previous 90 days.
  • Pregnant or breast-feeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Infections

Interventions

Amoxicillin-Potassium Clavulanate CombinationSaline Solution

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsCrystalloid SolutionsIsotonic SolutionsSolutions

Study Officials

  • Nizam Mamode

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Transplant Surgeon

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 18, 2014

Study Start

July 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

GB(1)