Drug SafetyPhase 3NCT01501968
Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity
A Phase 3 study testing Colistin and Colistin + Ascorbic acid in people with Drug Safety, run by Mahidol University at 1 site in Thailand.
Trial summary
Ascorbic acid (Vitamin C) could protect renal toxicity from colistin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Drug Safety
- What is being tested?
- Colistin and Colistin + Ascorbic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2012to Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years hospitalized patient who needs colistin for therapy of nosocomial infection
Who cannot join
- pregnant woman
- lactating mother
- allergy to ascorbic acid
- receiving non-steroidal antiinflammatory drugs (NSAID), aminoglycosides, vancomycin, cisplatin, amphotericin-B
- received radiocontrast media within 1 week
- renal stone
- G-6-PD deficiency
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Siriraj Hospital
Bangkok, Bangkok, 10700
Visanu Thamlikitkul, MD, 662-4197783, sivth@mahidol.ac.th
Visanu Thamlikitkul, MD
About this study
Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.
Read the detailed description
Renal toxicity due to colistin therapy is common. Ascorbic acid (vitamin C) has been shown to prevent colistin associated renal toxicity in animals. This study is conducted to determine if acorbic acid can prevent Colistin-Associated Nephrotoxicity.
- Conditions
- Drug Safety
- Being tested
- Colistin, Colistin + Ascorbic acid
- Keywords
- Colistin, ascorbic acid, renal toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColistinDrug
Also called Colistate
Colistimethate sodium 2.5-5mg/kg iv per day
Colistin + Ascorbic acidDrug
Also called vitamin c
Colistimethate sodium 2.5-5mg/kg iv per day and ascorbic acid 2 grams iv q 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Colistin | Active comparator | Colistimethate sodium 2.5-5mg/kg iv Receives: Drug: Colistin |
| Colistin + Ascorbic acid | Experimental | Colistimethate sodium 2.5-5mg/kg iv and ascorbic acid 2 grams iv every 12 hours Receives: Drug: Colistin + Ascorbic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with Renal toxicity associated with colistin
Renal toxicity associated with colistin according to RIFLE criteria
Measured: up to 28 days
Secondary outcomes (1)
number of subjects with cure or improvement
cure improvement worse death
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug SafetyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Siriraj Hospital
- Responsible party
- Sponsor
- Investigators
- Visanu Thamlikitkul, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501968
- Sponsor's protocol ID
- CEU 2012-01
- Status last verified
- Dec 2011
- First submitted
- 24 Dec 2011
- Last updated
- 30 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sirijatuphat R, Limmahakhun S, Sirivatanauksorn V, Nation RL, Li J, Thamlikitkul V. Preliminary clinical study of the effect of ascorbic acid on colistin-associated nephrotoxicity. Antimicrob Agents Chemother. 2015;59(6):3224-32. doi: 10.1128/AAC.00280-15. Epub 2015 Mar 23.
PubMed 25801556
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity
- ClinicalTrials.gov ID
- NCT01501968
- Acronym / sponsor ID
- CEU 2012-01
- Conditions
- Drug Safety
- Keywords
- Colistin, ascorbic acid, renal toxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Siriraj Hospital
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 30 Dec 2011 (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.
Ascorbic acid (Vitamin C) could protect renal toxicity from colistin.
Detailed description
Renal toxicity due to colistin therapy is common. Ascorbic acid (vitamin C) has been shown to prevent colistin associated renal toxicity in animals. This study is conducted to determine if acorbic acid can prevent Colistin-Associated Nephrotoxicity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colistin | Active comparator | Drug: ColistinColistimethate sodium 2.5-5mg/kg iv |
| Colistin + Ascorbic acid | Experimental | Drug: Colistin + Ascorbic acidColistimethate sodium 2.5-5mg/kg iv and ascorbic acid 2 grams iv every 12 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age > 18 years hospitalized patient who needs colistin for therapy of nosocomial infection
Key exclusion criteria (7 listed)
- pregnant woman
- lactating mother
- allergy to ascorbic acid
- receiving non-steroidal antiinflammatory drugs (NSAID), aminoglycosides, vancomycin, cisplatin, amphotericin-B
- received radiocontrast media within 1 week
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: ColistateColistimethate sodium 2.5-5mg/kg iv per day | Drug | Colistin |
| Colistin + Ascorbic acidAlso: vitamin cColistimethate sodium 2.5-5mg/kg iv per day and ascorbic acid 2 grams iv q 12 hours | Drug | Colistin + Ascorbic acid |
Primary outcome
number of patients with Renal toxicity associated with colistin
Time frame: up to 28 days
Renal toxicity associated with colistin according to RIFLE criteria
1 secondary outcome
number of subjects with cure or improvement
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2011.
- Derived from this study: PubMed 25801556Sirijatuphat R, Limmahakhun S, Sirivatanauksorn V, Nation RL, Li J, Thamlikitkul V. Preliminary clinical study of the effect of ascorbic acid on colistin-associated nephrotoxicity. Antimicrob Agents Chemother. 2015;59(6):3224-32. doi: 10.1128/AAC.00280-15. Epub 2015 Mar 23.
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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.
Visanu Thamlikitkul, MD principal investigator
Siriraj Hospital
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 Colistin and Colistin + Ascorbic acid in people with Drug Safety, run by Mahidol University at 1 site in Thailand.
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 7 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 30 Dec 2011. 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 Thailand. 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 Visanu Thamlikitkul, MD (662-419-7783, sivth@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with Renal toxicity associated with colistin (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01501968, which also lists 1 linked publication.
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 30 Dec 2011.