Antibiotic ProphylaxisPhase 3NCT05654896
Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma
A Phase 3 study testing Ceftriaxone Sodium in people with Antibiotic Prophylaxis, run by Nadeem Iqbal at 1 site in Pakistan.
Trial summary
This study aims to determine the effectiveness of prophylactic antibiotic use for TACE and occurrence of postoperative liver abscess. There would be two comparison groups. Current standard of care treatment at PKLI\&RC (as per local guidelines) would be given to all patients receiving TACE for the intervention group… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Antibiotic Prophylaxis
- What is being tested?
- Ceftriaxone Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Nov 2022to 26 Dec 2023
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary liver cancer or hepatocellular carcinoma.
- Patients receiving TACE in PKLI \& RC.
- Patients giving informed consent.
Who cannot join
- Receiving two or more TACE during the same hospitalization
- Use of any antibiotics other than the prophylactic antibiotic in 48hours prior to TACE
- Known hypersensitivity to specified antibiotic used in the study
- Incomplete or missing laboratory investigations and data
- Taking Sorafenib before TACE
- TACE combined with ablation or immunetherapy
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- Tumor size >10 cm
- Portal vein thrombosis
- Dilated biliary channels on CT scan / Billiary invasion by tumor
Trial locations and contacts
1 site in 1 country.
Muhammad Junaid Tahir, MBBS, BSC contact
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Kidney and Liver Institute
Lahore, Punjab Province, 54000
Nadeem Iqbal, FCPS*, +92 3345346538, dr_nadeemiqbal84@yahoo.com
About this study
Official title: Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma: an Open-label, Randomised, Prospective Study
This study aims to determine the effectiveness of prophylactic antibiotic use for TACE and occurrence of postoperative liver abscess.
There would be two comparison groups. Current standard of care treatment at PKLI\&RC (as per local guidelines) would be given to all patients receiving TACE for the intervention group or 'antibiotic group' (i.e., Inj. Ceftriaxone 1g, intravenous × stat). While no antibiotic would be given to the 'no antibiotic group'.
Read the detailed description
Liver cancer especially hepatocellular carcinoma (HCC) is among the top five most common carcinomas in the world. According to the latest Cardiovascular and Interventional Radiological Society of Europe (CIRSE) standards of practice guidelines (2021), routine antibiotic prophylaxis is not recommended. However, prophylactic antibiotics are recommended in cases where there is a high risk of developing a liver abscess. These include biliary obstruction or the presence of a bilioenteric anastomosis. This study aims to determine the effectiveness of prophylactic antibiotic use for TACE and occurrence of postoperative liver abscess.
- Conditions
- Antibiotic Prophylaxis
- Being tested
- Ceftriaxone Sodium
- Keywords
- Antibiotic, TACE, HCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftriaxone SodiumDrug
Antibiotic will be administered prophylactically for TACE
| Study group | Role | What they receive |
|---|---|---|
| No Antibiotic Prophylaxis Group | No intervention | No antibiotic will be administered prophylactically for TACE. |
| Antibiotic Prophylaxis Group | Experimental | Antibiotic will be administered prophylactically (i.e., Inj. Ceftriaxone 1g, intravenous × stat) Receives: Drug: Ceftriaxone Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocytosis
Predominantly neutrophilic leukocytosis ( > 11 ×109/L) with fever ( > 38 °C) in upto 48 hours post-TACE
Measured: 2 days
Liver abscess
Occurrence of liver abscess as diagnosed by imaging within 30 days of the procedure
Measured: 30 days
Liver abscess and intervention
Liver abscess requiring an intervention (e.g., percutaneous transhepatic abscess drainage (PTAD), percutaneous transhepatic abscess puncture or liver abscess incision) within 30 days of TACE
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start26 Nov 2022
- Primary completion26 Nov 2023 (estimated)
- Study completion26 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic ProphylaxisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nadeem Iqbal
- Sponsor type
- University, hospital or other
- Collaborators
- Ahmad Zia, Muhammad Junaid Tahir
- Responsible party
- Sponsor-investigator, Nadeem Iqbal, Pakistan Kidney and Liver Institute and Research Center
- Investigators
- Ahmad Zia Ud Din, Principal investigator, PKLI & RC, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654896
- Sponsor's protocol ID
- PKLI-IRB/AP/89
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotic Use in Transarterial Chemoembolization for Hepatocellular Carcinoma: an Open-label, Randomised, Prospective Study
- ClinicalTrials.gov ID
- NCT05654896
- Acronym / sponsor ID
- PKLI-IRB/AP/89
- Conditions
- Antibiotic Prophylaxis
- Keywords
- Antibiotic, TACE, HCC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Nadeem IqbalUniversity, hospital or other
- Collaborators
- Ahmad Zia, Muhammad Junaid Tahir
- Study start
- 26 Nov 2022 (actual)
- Primary completion
- 26 Nov 2023 (estimated)
- Study completion
- 26 Dec 2023 (estimated)
- First posted
- 16 Dec 2022 (actual)
- 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.
This study aims to determine the effectiveness of prophylactic antibiotic use for TACE and occurrence of postoperative liver abscess.
There would be two comparison groups. Current standard of care treatment at PKLI\&RC (as per local guidelines) would be given to all patients receiving TACE for the intervention group or 'antibiotic group' (i.e., Inj. Ceftriaxone 1g, intravenous × stat). While no antibiotic would be given to the 'no antibiotic group'.
Detailed description
Liver cancer especially hepatocellular carcinoma (HCC) is among the top five most common carcinomas in the world. According to the latest Cardiovascular and Interventional Radiological Society of Europe (CIRSE) standards of practice guidelines (2021), routine antibiotic prophylaxis is not recommended. However, prophylactic antibiotics are recommended in cases where there is a high risk of developing a liver abscess. These include biliary obstruction or the presence of a bilioenteric anastomosis. This study aims to determine the effectiveness of prophylactic antibiotic use for TACE and occurrence of postoperative liver abscess.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Antibiotic Prophylaxis Group | No intervention | –No antibiotic will be administered prophylactically for TACE. |
| Antibiotic Prophylaxis Group | Experimental | Drug: Ceftriaxone SodiumAntibiotic will be administered prophylactically (i.e., Inj. Ceftriaxone 1g, intravenous × stat) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of primary liver cancer or hepatocellular carcinoma.
- Patients receiving TACE in PKLI \& RC.
- Patients giving informed consent.
Key exclusion criteria (9 listed)
- Receiving two or more TACE during the same hospitalization
- Use of any antibiotics other than the prophylactic antibiotic in 48hours prior to TACE
- Known hypersensitivity to specified antibiotic used in the study
- Incomplete or missing laboratory investigations and data
- Taking Sorafenib before TACE
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 |
|---|---|---|
| Ceftriaxone SodiumAntibiotic will be administered prophylactically for TACE | Drug | Antibiotic Prophylaxis Group |
Primary outcome
Leukocytosis
Time frame: 2 days
Predominantly neutrophilic leukocytosis ( > 11 ×109/L) with fever ( > 38 °C) in upto 48 hours post-TACE
Liver abscess
Time frame: 30 days
Occurrence of liver abscess as diagnosed by imaging within 30 days of the procedure
Liver abscess and intervention
Time frame: 30 days
Liver abscess requiring an intervention (e.g., percutaneous transhepatic abscess drainage (PTAD), percutaneous transhepatic abscess puncture or liver abscess incision) within 30 days of TACE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Muhammad Junaid Tahir, MBBS, BSC contact
Ahmad Zia Ud Din principal investigator
PKLI & RC, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ceftriaxone Sodium in people with Antibiotic Prophylaxis, run by Nadeem Iqbal at 1 site in Pakistan.
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 3 inclusion and 9 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 16 Dec 2022. 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 Pakistan. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Ahmad Zia Ud Din, MBBS, FRCR (+923028099040, ahmad.zia@pkli.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukocytosis (time frame: 2 days). The study lists 3 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 16 Dec 2022.