Gram Negative Bacterial InfectionsPhase 4NCT02117986
Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients
A Phase 4 study testing colistin in people with Gram Negative Bacterial Infections, run by Hospital Barros Luco Trudeau at 2 sites in Chile.
Trial summary
The study hypothesis is that the loading dose of intravenous colistin (6 million of international units) is associated with greater clinical and microbiological efficacy, and reduced mortality of critically ill patients infected by multidrug resistant Gram- negative bacilli, compared to a scheme without loading dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram Negative Bacterial Infections
- What is being tested?
- colistin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChile
- Study dates
- Apr 2014to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient hospitalized in critical care units
- patient infected by multi drug resistant Gram negative bacteria susceptibly only to colistin
- source of infection: blood, respiratory, intra abdominal or urinary
Who cannot join
- pregnant or breastfeeding patients
- patient with a history of hypersensitivity to colistin
Trial locations and contacts
2 sites in 1 country.
Chile2 sites, 2 recruiting
- Recruiting
Hospital de Puerto Montt
Port Montt, 5507798
Loreto Rojas, PhD, +56968479281, rojasloreto@gmail.com
Susana Hernandez, Pharm, +56976373749, shernandez@ssdr.gob.cl
- Recruiting
Hospital Barros Luco Trudeau
Santiago, Santiago Metropolitan, 8900085
Loreto Rojas, MD, 56-9-68479281, rojasloreto@gmail.com
Ruth Rosales, PharmD, 56-9-9093184, ruth.rosales@vtr.net
About this study
Official title: Clinical and Microbiological Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients
The study hypothesis is that the loading dose of intravenous colistin (6 million of international units) is associated with greater clinical and microbiological efficacy, and reduced mortality of critically ill patients infected by multidrug resistant Gram- negative bacilli, compared to a scheme without loading dose.
Read the detailed description
It is a prospective, multicenter, randomized, controlled study to evaluate a scheme with and without a loading dose of 6 million international units of colistin, followed by a maintenance dose of 3 million international units every 8 hours intravenous. The study should be conducted in 3 hospitals in Chile, in critically patients presenting infection by multidrug Gram-negative bacteria and requiring be treated with colistin for at least 48 hours. The objectives of the study are: to evaluate the clinical and microbiological response, and mortality.
- Conditions
- Gram Negative Bacterial Infections
- Being tested
- colistin
- Keywords
- critically ill patients, colistin dosing, multidrug resistant bacteria
- Medical subject headings
- Gram-Negative Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colistinDrug
Also called colistimethate sodium, polymyxin e
One arm will receive a loading dose of colistin (6 million international units), and a maintenance dose of 3 million every 8 hours. The other arm will receive a maintenance dose of 3 million international units every 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| loading dose of colistin | Experimental | Patients will receive a loading dose of colistin (6 million international units) followed by a maintenance dose of 3 million international units of colistin every 8 hours intravenous Receives: Drug: colistin |
| without loading dose of colistin | Active comparator | Patients will receive 3 million international units of colistin every 8 hours intravenous Receives: Drug: colistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with clinical response to treatment
remission or reduction of clinical signs of infection
Measured: up to 1 week
percentage of patients with microbiological response
negative culture at the same site where the positive culture was obtained before
Measured: up to 1 week
mortality
the mortality during their stay in the intensive care unit, an expected average of 4 weeks
Measured: during their stay in the intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram Negative Bacterial InfectionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Barros Luco Trudeau
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Responsible party
- Sponsor
- Investigators
- Loreto Rojas, MD, PhD, Principal investigator, Hospital Barros Luco Trudeau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117986
- Sponsor's protocol ID
- SA13I20317
- Status last verified
- Mar 2018
- First submitted
- 2 Apr 2014
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Efficacy and Mortality of a Loading Dose of Colistin in Critical Ill Patients
- ClinicalTrials.gov ID
- NCT02117986
- Acronym / sponsor ID
- SA13I20317
- Conditions
- Gram Negative Bacterial Infections
- Keywords
- critically ill patients, colistin dosing, multidrug resistant bacteria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Barros Luco TrudeauUniversity, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Study start
- Apr 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Apr 2014 (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 study hypothesis is that the loading dose of intravenous colistin (6 million of international units) is associated with greater clinical and microbiological efficacy, and reduced mortality of critically ill patients infected by multidrug resistant Gram- negative bacilli, compared to a scheme without loading dose.
Detailed description
It is a prospective, multicenter, randomized, controlled study to evaluate a scheme with and without a loading dose of 6 million international units of colistin, followed by a maintenance dose of 3 million international units every 8 hours intravenous. The study should be conducted in 3 hospitals in Chile, in critically patients presenting infection by multidrug Gram-negative bacteria and requiring be treated with colistin for at least 48 hours. The objectives of the study are: to evaluate the clinical and microbiological response, and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| loading dose of colistin | Experimental | Drug: colistinPatients will receive a loading dose of colistin (6 million international units) followed by a maintenance dose of 3 million international units of colistin every 8 hours intravenous |
| without loading dose of colistin | Active comparator | Drug: colistinPatients will receive 3 million international units of colistin every 8 hours intravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient hospitalized in critical care units
- patient infected by multi drug resistant Gram negative bacteria susceptibly only to colistin
- source of infection: blood, respiratory, intra abdominal or urinary
Key exclusion criteria (2 listed)
- pregnant or breastfeeding patients
- patient with a history of hypersensitivity to colistin
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 |
|---|---|---|
| colistinAlso: colistimethate sodium, polymyxin eOne arm will receive a loading dose of colistin (6 million international units), and a maintenance dose of 3 million every 8 hours. The other arm will receive a maintenance dose of 3 million international units every 8 hours. | Drug | loading dose of colistin, without loading dose of colistin |
Primary outcome
Percentage of patients with clinical response to treatment
Time frame: up to 1 week
remission or reduction of clinical signs of infection
percentage of patients with microbiological response
Time frame: up to 1 week
negative culture at the same site where the positive culture was obtained before
mortality
Time frame: during their stay in the intensive care unit
the mortality during their stay in the intensive care unit, an expected average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
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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.
Loreto Rojas, MD, PhD principal investigator
Hospital Barros Luco Trudeau
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing colistin in people with Gram Negative Bacterial Infections, run by Hospital Barros Luco Trudeau at 2 sites in Chile.
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 2 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 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. 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 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?
Contact Loreto Rojas, MD (56-9-68479281, rojasloreto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with clinical response to treatment (time frame: up to 1 week). 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 13 Mar 2018.