Infectious DiseasesPhase 4NCT02162966
Safety and Efficacy Study of High Dose Colistin
A Phase 4 study testing High Dose Colistin and Standard Dose Colistin in people with Infectious Diseases, run by King Saud Medical City at 1 site in Saudi Arabia.
Trial summary
Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa, Acinetobacterbaumannii, and Klebsiella pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Diseases
- What is being tested?
- High Dose Colistin and Standard Dose Colistin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- May 2014to Oct 2016
- 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 age more than or equal 18 years old.
- Patient has clinical signs and symptoms of infection with suspected or proven infection due to Carbapenem resistant microorganism.
- Patient was started with Empirical therapy of Colistin and positive MDRO within 5 days of empirical therapy.
Who cannot join
- Patient age less than 18 years.
- Pregnant patient.
- If received Colistin treatment for less than 72 hours.
- Renal Replacement Therapy.
Trial locations and contacts
1 site in 1 country.
Basheer M Abdelrahman, pharmD contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Saud Medical City
Riyadh, Riyadh Region, 00966
Ahmed F Mady, PhD, 00966547060770, afmady@ksmc.med.sa
Ahmad F Mady, PhD
About this study
Official title: Use Of High Dose Colistin in Multi Drug Resistant Gram Negative Infections in Critically Ill Adult Patients. Randomized Controlled Clinical Trial
Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa, Acinetobacterbaumannii, and Klebsiella pneumonia.
- Conditions
- Infectious Diseases
- Being tested
- High Dose Colistin, Standard Dose Colistin
- Keywords
- colistin, ICU, critical care
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose ColistinDrug
Also called colistin
High Dose Colistin
Standard Dose ColistinDrug
Also called Colistin
Standard Dose Colistin
| Study group | Role | What they receive |
|---|---|---|
| High Dose Colistin | Experimental | High dose colistin protocol Receives: Drug: High Dose Colistin |
| Standard Dose Colistin | Active comparator | Standard dose of colistin Receives: Drug: Standard Dose Colistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety of high dose Colistin
Evaluate the safety of high dose Colistin to treat MDRO infection in critically ill patients.
The safety of high dose Colistin will be determined by number of participants whom renal function will be deviated from the baseline after administering high dose of Colistin.
Measured: 7 to 21 days after giving Colistin
Secondary outcomes (4)
All cause mortality
Measured: 7 days after the end of therapy or at 28 days after enrollment
Ventilation free days
Measured: 28 days after enrollment
Length of ICU stay
Measured: 28 days after enrollment
Microbiological response
whole body cultures will be done at day 7 of treatment and at the end of therapy
Measured: A day 7 and at the end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseasesStudies 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
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud Medical City
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ahmed F Mady, PhD, Principal investigator, King Saud Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162966
- Sponsor's protocol ID
- KSMC-CCD-AFM-002
- Status last verified
- Mar 2015
- First submitted
- 21 May 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of High Dose Colistin in Multi Drug Resistant Gram Negative Infections in Critically Ill Adult Patients. Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02162966
- Acronym / sponsor ID
- KSMC-CCD-AFM-002
- Conditions
- Infectious Diseases
- Keywords
- colistin, ICU, critical care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- King Saud Medical CityOther government
- Study start
- May 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 13 Jun 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.
Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa, Acinetobacterbaumannii, and Klebsiella pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose Colistin | Experimental | Drug: High Dose ColistinHigh dose colistin protocol |
| Standard Dose Colistin | Active comparator | Drug: Standard Dose ColistinStandard dose of colistin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| High Dose ColistinAlso: colistinHigh Dose Colistin | Drug | High Dose Colistin |
| Standard Dose ColistinAlso: ColistinStandard Dose Colistin | Drug | Standard Dose Colistin |
Primary outcome
Evaluate safety of high dose Colistin
Time frame: 7 to 21 days after giving Colistin
Evaluate the safety of high dose Colistin to treat MDRO infection in critically ill patients. The safety of high dose Colistin will be determined by number of participants whom renal function will be deviated from the baseline after administering high dose of Colistin.
4 secondary outcomes
All cause mortality
Time frame: 7 days after the end of therapy or at 28 days after enrollment
Ventilation free days
Time frame: 28 days after enrollment
Length of ICU stay
Time frame: 28 days after enrollment
Microbiological response
Time frame: A day 7 and at the end of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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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.
Basheer M Abdelrahman, pharmD contact
Ahmed F Mady, PhD principal investigator
King Saud Medical City
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 High Dose Colistin and Standard Dose Colistin in people with Infectious Diseases, run by King Saud Medical City at 1 site in Saudi Arabia.
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 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: status not confirmed, as of the sponsor's last update on 1 Apr 2015. 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 Saudi Arabia. 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 Ahmed F Mady, PhD (00966547060770, afmady@ksmc.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety of high dose Colistin (time frame: 7 to 21 days after giving Colistin). 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 1 Apr 2015.