InfectionPhase 4NCT01870167
Antibiotic Prophylaxis for PEG in Children
A Phase 4 study testing co-amoxiclav in people with Infection, run by Azienda Policlinico Umberto I at 1 site in Italy.
Trial summary
The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Infection
- What is being tested?
- co-amoxiclav
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All pediatric patients (0-18 years) who will refer for PEG placement to the endoscopy unit
Who cannot join
- Controindications for PEG
- Ongoing antibiotic treatment
- Antibiotic use within the past 4 days
- Illness too severe to allow the patient to participate
- Allergy to penicillin
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Pediatrics
Rome, 00161
Department of Pediatrics, 0649979326, giovanni.dinardo@uniroma1.it
About this study
Official title: Antibiotic Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG) in Children: a Randomised Controlled Trial.
The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.
Read the detailed description
Percutaneous Endoscopic Gastrostomy (PEG) is a common endoscopic procedure, performed to avoid malnutrition in various pathological conditions.
Gastrostomy tube placement is associated with intra and postoperative complications both in the adult and in the paediatric population.
Local infection is the most common complication following PEG.
Antibiotic prophylaxis is a well-established strategy to reduce peristomal wound infection rate in adult population.
The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.
- Conditions
- Infection
- Being tested
- co-amoxiclav, Placebo
- Keywords
- PEG, Percutaneous Endoscopic Gastrostomy, antibiotic prophylaxis
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
co-amoxiclavDrug
a single iv dose of co-amoxiclav (50/mg/Kg) at the time of PEG insertion.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
| co-amoxiclav | Experimental | co-amoxiclav is a combination antibiotic consisting of amoxicillin trihydrate, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor Receives: Drug: co-amoxiclav |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
24 hours after PEG insertion PEG site will be examined for erythema, induration and exudate and scored using the peristomal sepsis scoring system.
PEG site infection will be defined as presence of pus or a score of 8 or more, with or without microbiological evidence of bacterial or fungal infection from PEG site swabs.
Measured: 24 hours after PEG insertion
Efficacy
14 days after PEG insertion PEG site will be examined for erythema, induration and exudate and scored using the peristomal sepsis scoring system.
Measured: 14 days after PEG insertion
Secondary outcomes (2)
Efficacy
Secondary outcomes are occurrence of systemic infection, defined as persistent fever (temperature >38.0 °C for >24 h) or clinical, laboratory and microbiological evidence of invasive sepsis and objective signs of infection, including a positive bacterial or fungal culture, high levels of highly sensitive C reactive protein, and a high white blood cell count.
Measured: 24 hours after PEG insertion
Efficacy
Secondary outcomes are occurrence of systemic infection, defined as persistent fever (temperature >38.0 °C for >24 h) or clinical, laboratory and microbiological evidence of invasive sepsis and objective signs of infection, including a positive bacterial or fungal culture, high levels of highly sensitive C reactive protein, and a high white blood cell count.
Measured: 14 days after PEG insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Policlinico Umberto I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Di Nardo, Azienda Policlinico Umberto I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870167
- Sponsor's protocol ID
- Pediatric- PEG
- Status last verified
- May 2013
- First submitted
- 14 May 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG) in Children: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT01870167
- Acronym / sponsor ID
- Pediatric- PEG
- Conditions
- Infection
- Keywords
- PEG, Percutaneous Endoscopic Gastrostomy, antibiotic prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Azienda Policlinico Umberto IUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.
Detailed description
Percutaneous Endoscopic Gastrostomy (PEG) is a common endoscopic procedure, performed to avoid malnutrition in various pathological conditions.
Gastrostomy tube placement is associated with intra and postoperative complications both in the adult and in the paediatric population.
Local infection is the most common complication following PEG.
Antibiotic prophylaxis is a well-established strategy to reduce peristomal wound infection rate in adult population.
The aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before PEG can reduce the incidence of peristomal wound infection in the paediatric population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
| co-amoxiclav | Experimental | Drug: co-amoxiclavco-amoxiclav is a combination antibiotic consisting of amoxicillin trihydrate, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All pediatric patients (0-18 years) who will refer for PEG placement to the endoscopy unit
Key exclusion criteria (5 listed)
- Controindications for PEG
- Ongoing antibiotic treatment
- Antibiotic use within the past 4 days
- Illness too severe to allow the patient to participate
- Allergy to penicillin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| co-amoxiclava single iv dose of co-amoxiclav (50/mg/Kg) at the time of PEG insertion. | Drug | co-amoxiclav |
| PlaceboPlacebo | Dietary supplement | placebo |
Primary outcome
Efficacy
Time frame: 24 hours after PEG insertion
24 hours after PEG insertion PEG site will be examined for erythema, induration and exudate and scored using the peristomal sepsis scoring system. PEG site infection will be defined as presence of pus or a score of 8 or more, with or without microbiological evidence of bacterial or fungal infection from PEG site swabs.
Efficacy
Time frame: 14 days after PEG insertion
14 days after PEG insertion PEG site will be examined for erythema, induration and exudate and scored using the peristomal sepsis scoring system.
2 secondary outcomes
Efficacy
Time frame: 24 hours after PEG insertion
Efficacy
Time frame: 14 days after PEG insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing co-amoxiclav in people with Infection, run by Azienda Policlinico Umberto I at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 24 hours after PEG insertion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.