Pharmacokinetic Parameters of Co-trimoxazole

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Rationale:

Treatment of multidrug or extensively drug resistant tuberculosis (MDR/XDR-TB) is a real challenge as failure in response to treatment and serious side-effects are frequently encountered. New, more effective drugs with less side effects are therefore urgently needed to solve this problem. Although several new drugs against TB are in the pipeline, physicians currently have limited treatment options for treatment of complicated MDR/XDR-TB cases. Therefore, drugs developed and labeled for other infectious diseases are evaluated for TB. Co-trimoxazole consists of sulfamethoxazole and trimethoprim. Sulfamethoxazole could be effective in the treatment of tuberculosis as shown by Forgacs et al. and Huang et al.

Furthermore, with dried blood spot (DBS) analysis, the exposure to co-trimoxazole could be analyzed with only some blood drops withdrawn with a finger prick on paper. This paper is suitable for storage, transportation and subsequently analysis without additional cooling or storage requirements.

Objective:

The main objective of this prospective clinical trial is to evaluate pharmacokinetics of 960 mg co-trimoxazole in TB patients. This clinical trial will provide important information on PK of co-trimoxazole in TB patients for future studies.

The second objective is to calculate the T\>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio as efficacy predicting parameter. Furthermore, the analysis of dried blood spots will be clinically validated by comparing results of blood samples withdrawn from venous blood versus withdrawn by finger prick and transferred to filter paper. Retrospectively, data from this study can be used for limited sampling strategies for co-trimoxazole based on a pharmacokinetic population model constructed from the full PK curves of the patients.

Study design:

A prospective pharmacokinetic study.

Study population: 12 TB patients.

Intervention: on 4 to 6 days, 960 mg co-trimoxazole daily will be added to the normal treatment regimen.

Main study parameters/endpoints:

The pharmacokinetic parameters (Vd, Cl, AUC, etc) of co-trimoxazole are the primary endpoints of the study. The T\>MIC and AUC0-24h/Minimal inhibitory concentration (MIC) ratio are most likely the best predictive parameters for efficacy of co-trimoxazole treatment and will be calculated for a range of M tuberculosis isolates.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Disturbance of the Intestinal Microbiota by Temocillin vs Cefotaxime in Treatment of Febrile Urinary Tract Infections

NCT02959957

Urinary Tract Infections

COMPLETED PHASE4

Plasma Protein Binding and PK/PD of Total and Unbound Temocillin Non-ICU Patients

NCT03557840

Pharmacokinetics Antibacterial Agents Infections, Bacterial +3 more

UNKNOWN NA

Human Microbiome and Healthcare Associated Infections - Nursing Home Dwelling Older Veterans

NCT04218799

Human Microbiome

COMPLETED PHASE4

Clinical Usefulness of Therapeutic Drug Monitoring of Colistin in Patients Treated With Colistin.

NCT03007290

Multidrug-resistant Gram-negative Bacteria Infection

COMPLETED NA

DetectAB - Detecting Antibiotics

NCT03678142

Antibiotic Drug Concentration in Sweat

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

co-trimoxazole

On 4, 5 or 6 consecutive days, 960 mg co-trimoxazole (oral) will be added to the normal treatment of tuberculosis.

Group Type EXPERIMENTAL

co-trimoxazole

Intervention Type DRUG

On 4, 5 or 6 consecutive days, co-trimoxazole 960 mg will be added to the normal treatment regimen

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

co-trimoxazole

On 4, 5 or 6 consecutive days, co-trimoxazole 960 mg will be added to the normal treatment regimen

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sulfamethoxazole/trimethoprim

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* TB Patients with normal susceptible Mycobacterium tuberculosis
* Patients older than 17 and younger than 64 years.

Exclusion Criteria

* Pregnancy or breast feeding
* Patients with hypersensitivity to sulfonamide or trimethoprim
* Concomitant treatment with vitamin K antagonists (acenocoumarol)
* Patients with preexisting renal dysfunction or concomitant treatment of angiotensin converting enzyme inhibitors and potassium -sparing diuretics) that may exacerbate the hyperkalemic effect of SXT.
* Patients treated with methotrexate, phenytoin, sulfonylureas (glibenclamide, gliclazide, glimepiride en tolbutamide) or procainamide hydrochloride.
* Patients that have gastrointestinal complaints like diarrhea and vomiting (observed)
* Patients that have experienced an adverse effect to SXT or similar antibiotic drugs.
* Patients with HIV or AIDS.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No