SepsisPhase 3NCT01862185
The Effect of Semi-quantitative Procalcitonin Assay to The Adequacy of Empirical Antibiotics and Mortality in Septic Patients
A Phase 3 study testing semi-quantitative procalcitonin in people with Sepsis, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Sepsis is a serious clinical condition with a considerable morbidity and mortality. Procalcitonin (PCT) is a good biomarker for early diagnosis and infection monitoring. The present study aimed to investigate the effect of semi-quantitative PCT test to the empirical antibiotic initiation time, the appropriateness of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- semi-quantitative procalcitonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteIndonesia
- Study dates
- Dec 2012to Apr 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged more than 18 years old
- have at least two concomitant systemic inflammatory response syndrome criteria
- have focal infection
- with or without sign of organ hypoperfusion or dysfunction
Who cannot join
- post operative patient
- trauma patient
- have obtained prior antibiotic
- refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pengaruh Pemeriksaan Procalcitonin Semikuantitatif Terhadap Adekuasi Terapi Antibiotik Empirik Awal Dan Mortalitas Pada Pasien Sepsis
Sepsis is a serious clinical condition with a considerable morbidity and mortality. Procalcitonin (PCT) is a good biomarker for early diagnosis and infection monitoring. The present study aimed to investigate the effect of semi-quantitative PCT test to the empirical antibiotic initiation time, the appropriateness of empirical antibiotics and mortality in septic patients.
The hypothesis of the study are :
Read more
- There is an effect on mortality between septic patients who do and do not do semi-quantitative PCT examination
- There is an effect on empirical antibiotic initiation time between septic patients who do and do not do semi-quantitative PCT examination
- There is an effect on appropriateness of empirical antibiotic between septic patients who do and do not do semi-quantitative PCT examination
Study design is randomized diagnostic trial which is also a pragmatic trial.
- Conditions
- Sepsis
- Being tested
- semi-quantitative procalcitonin
- Keywords
- semiquantitative, procalcitonin, sepsis, antibiotics, mortality
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-quantitative procalcitoninOther
Also called PCT-Q
| Study group | Role | What they receive |
|---|---|---|
| semi-quantitative procalcitonin | Experimental | patients whom checked semi-quantitative procalcitonin examination Receives: Other: semi-quantitative procalcitonin |
| control | No intervention | patients whom do not checked semi-quantitative procalcitonin examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
mortality in 14 days since the patients were included in this study
Measured: 14 days
Secondary outcomes (2)
the timing of empirical antibiotic first dose
when does the patient get their first dose of empirical antibiotic in 24 hours since the patient was diagnosis as sepsis?
Measured: in 24 hours since the patient was diagnosis as sepsis
the appropriateness of empirical antibiotic
does the empirical antibiotic that given in 24 hours since the patient was diagnosis as sepsis is effective?
Measured: in 24 hours since the patient was diagnosed as sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Dharaniyadewi, Universitas Indonesia
- Investigators
- Dana Dharaniyadewi, MD, Principal investigator, Faculty of Medicine, Indonesia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862185
- Sponsor's protocol ID
- AB-PCTQ1
- Status last verified
- Mar 2014
- First submitted
- 20 May 2013
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pengaruh Pemeriksaan Procalcitonin Semikuantitatif Terhadap Adekuasi Terapi Antibiotik Empirik Awal Dan Mortalitas Pada Pasien Sepsis
- ClinicalTrials.gov ID
- NCT01862185
- Acronym / sponsor ID
- AB-PCTQ1
- Conditions
- Sepsis
- Keywords
- semiquantitative, procalcitonin, sepsis, antibiotics, mortality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 May 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.
Sepsis is a serious clinical condition with a considerable morbidity and mortality. Procalcitonin (PCT) is a good biomarker for early diagnosis and infection monitoring. The present study aimed to investigate the effect of semi-quantitative PCT test to the empirical antibiotic initiation time, the appropriateness of empirical antibiotics and mortality in septic patients.
The hypothesis of the study are :
- There is an effect on mortality between septic patients who do and do not do semi-quantitative PCT examination
- There is an effect on empirical antibiotic initiation time between septic patients who do and do not do semi-quantitative PCT examination
- There is an effect on appropriateness of empirical antibiotic between septic patients who do and do not do semi-quantitative PCT examination
Study design is randomized diagnostic trial which is also a pragmatic trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| semi-quantitative procalcitonin | Experimental | Other: semi-quantitative procalcitoninpatients whom checked semi-quantitative procalcitonin examination |
| control | No intervention | –patients whom do not checked semi-quantitative procalcitonin examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged more than 18 years old
- have at least two concomitant systemic inflammatory response syndrome criteria
- have focal infection
- with or without sign of organ hypoperfusion or dysfunction
Key exclusion criteria (4 listed)
- post operative patient
- trauma patient
- have obtained prior antibiotic
- refused to participate
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 |
|---|---|---|
| semi-quantitative procalcitoninAlso: PCT-Q | Other | semi-quantitative procalcitonin |
Primary outcome
mortality rate
Time frame: 14 days
mortality in 14 days since the patients were included in this study
2 secondary outcomes
the timing of empirical antibiotic first dose
Time frame: in 24 hours since the patient was diagnosis as sepsis
the appropriateness of empirical antibiotic
Time frame: in 24 hours since the patient was diagnosed as sepsis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
Related trials for Sepsis
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A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
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CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Dana Dharaniyadewi, MD principal investigator
Faculty of Medicine, Indonesia University
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 semi-quantitative procalcitonin in people with Sepsis, run by Universitas Indonesia at 1 site in Indonesia.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 7 Mar 2014. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: 14 days). 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 7 Mar 2014.