Autoimmune DiseasesNCT05042271
PK of Meropenem in Patients on Plasma Exchange
An observational study of Autoimmune Diseases, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Therapeutic plasma exchange (TPE) has been shown to be an important procedure for treatment of a variety of refractory immune complex disorders, such as Guillain-Barré syndrome and neuromyelitis optica. The intervention removes plasma, albumin, or some other substance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- meropenem
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Observational
- 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
Study population: autoimmune diseases
Who may be able to join
- age≥ 18 years
- no shock
- hemoglobin ≥ 7 g/dl
Who cannot join
- pregnancy or breast-feeding female
- history of hypersensitivity to carbapenems
- renal replacement therapy
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Prince of Songkla University, Thailand
Hat Yai, Changwat Songkhla, 90110
Sutep Jaruratanasirikul, M.D., 6674-451485, jasutep@medicine.psu.ac.th
Monchana Nawakitrangsan, M.Pharm, 6674-451486, nana_jittung@hotmail.com
About this study
Official title: Pharmacokinetics of Meropenem in Patients on Plasma Exchange
Therapeutic plasma exchange (TPE) has been shown to be an important procedure for treatment of a variety of refractory immune complex disorders, such as Guillain-Barré syndrome and neuromyelitis optica. The intervention removes plasma, albumin, or some other substance. Meropenem is a broad-spectrum beta-lactam antimicrobial agent that is used for the treatment of serious nosocomial infections. Pathophysiological changes in patients on TPE can alter the pharmacokinetic (PK) patterns of coadministered antibiotics. This effect has an impact on the antimicrobial agents when paticipants are administered during the intervention. The aim of this study was to investigate the impact of TPE on meropenem PK.
- Conditions
- Autoimmune Diseases
- Being tested
- meropenem
- Keywords
- therapeutic plasma exchange, meropenem, pharmacokinetic
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meropenemDrug
each patient received a 1 hour infusion of a single dose of 1 g of meropenem diluted in 100 ml of normal saline solution, at the same time as the start of the first TPE and meropenem PK studies were carried out after the administration of meropenem. Blood samples (3 ml) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hours after the start of the meropenem administration.
| Study group | Role | What they receive |
|---|---|---|
| Meropenem: Patients who underwent TPE (Phase 1) | In phase 1, each patient received a 1 hour infusion of a single dose of 1 g of meropenem diluted in 100 ml of normal saline solution, at the same time as the start of the first therapeutic plasma exchange (TPE) and meropenem PK studies were carried out after the administration of meropenem. Blood samples (3 ml) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hours after the start of the meropenem administration. Receives: Drug: meropenem | |
| Meropenem: after TPE (Phase 2) | was similar to phase 1 except that the meropenem administration and PK studies were conducted >6 hours apart from the next TPE Receives: Drug: meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
The plasma concentrations were measured at the following times: 0, 0.25, 0.5, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hour after the start of drug administration
Measured: 0-8 hours after the drug administration
Secondary outcomes (4)
Maximum plasma concentration [Cmax]
Measured: 0-8 hours after the drug administration
Minimum plasma concentration [Cmin]
Measured: 0-8 hours after the drug administration
Area under the plasma concentration versus time curve [AUC]
Measured: 0-8 hours after the drug administration
half-life [t1/2]
Measured: 0-8 hours after the drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Jan 2020
- Primary completion18 Oct 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sutep Jaruratanasirikul, Prince of Songkla University
- Investigators
- Sutep Jaruratanasirikul, M.D., Principal investigator, Faculty of Medicine, Prince of Songkla University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042271
- Sponsor's protocol ID
- meropenem-plasma exchange
- Status last verified
- Sep 2021
- First submitted
- 13 Jul 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Meropenem in Patients on Plasma Exchange
- ClinicalTrials.gov ID
- NCT05042271
- Acronym / sponsor ID
- meropenem-plasma exchange
- Conditions
- Autoimmune Diseases
- Keywords
- therapeutic plasma exchange, meropenem, pharmacokinetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 18 Oct 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Sep 2021 (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.
Therapeutic plasma exchange (TPE) has been shown to be an important procedure for treatment of a variety of refractory immune complex disorders, such as Guillain-Barré syndrome and neuromyelitis optica. The intervention removes plasma, albumin, or some other substance. Meropenem is a broad-spectrum beta-lactam antimicrobial agent that is used for the treatment of serious nosocomial infections. Pathophysiological changes in patients on TPE can alter the pharmacokinetic (PK) patterns of coadministered antibiotics. This effect has an impact on the antimicrobial agents when paticipants are administered during the intervention. The aim of this study was to investigate the impact of TPE on meropenem PK.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropenem: Patients who underwent TPE (Phase 1) | – | Drug: meropenemIn phase 1, each patient received a 1 hour infusion of a single dose of 1 g of meropenem diluted in 100 ml of normal saline solution, at the same time as the start of the first therapeutic plasma exchange (TPE) and meropenem PK studies were carried out after the administration of meropenem. Blood samples (3 ml) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hours after the start of the meropenem administration. |
| Meropenem: after TPE (Phase 2) | – | Drug: meropenemwas similar to phase 1 except that the meropenem administration and PK studies were conducted >6 hours apart from the next TPE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- autoimmune diseases
Key inclusion criteria (3 listed)
- age≥ 18 years
- no shock
- hemoglobin ≥ 7 g/dl
Key exclusion criteria (3 listed)
- pregnancy or breast-feeding female
- history of hypersensitivity to carbapenems
- renal replacement therapy
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 |
|---|---|---|
| meropenemeach patient received a 1 hour infusion of a single dose of 1 g of meropenem diluted in 100 ml of normal saline solution, at the same time as the start of the first TPE and meropenem PK studies were carried out after the administration of meropenem. Blood samples (3 ml) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hours after the start of the meropenem administration. | Drug | Meropenem: Patients who underwent TPE (Phase 1), Meropenem: after TPE (Phase 2) |
Primary outcome
The plasma concentrations were measured at the following times: 0, 0.25, 0.5, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hour after the start of drug administration
Time frame: 0-8 hours after the drug administration
4 secondary outcomes
Maximum plasma concentration [Cmax]
Time frame: 0-8 hours after the drug administration
Minimum plasma concentration [Cmin]
Time frame: 0-8 hours after the drug administration
Area under the plasma concentration versus time curve [AUC]
Time frame: 0-8 hours after the drug administration
half-life [t1/2]
Time frame: 0-8 hours after the drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
Related trials for Autoimmune Diseases
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
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.
Sutep Jaruratanasirikul, M.D. principal investigator
Faculty of Medicine, Prince of Songkla University, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases, run by Prince of Songkla 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 3 inclusion and 3 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 Sep 2021. 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.
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 Sutep Jaruratanasirikul, M.D. (66741485, jasutep@medicine.psu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The plasma concentrations were measured at the following times: 0, 0.25, 0.5, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hour after the start of drug administration (time frame: 0-8 hours after the drug administration). 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 Sep 2021.