Trial reportThe Journal of antimicrobial chemotherapy2021
Levofloxacin pharmacokinetics in saliva as measured by a mobile microvolume UV spectrophotometer among people treated for rifampicin-resistant TB in Tanzania.
Trial report in The Journal of antimicrobial chemotherapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04124055 (Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Can we Predict Drug Excretion into Saliva? A Systematic Review and Analysis of Physicochemical Properties.Clinical pharmacokinetics · 2024Pooled it
- Alternative Methods for Therapeutic Drug Monitoring and Dose Adjustment of Tuberculosis Treatment in Clinical Settings: A Systematic Review.Clinical pharmacokinetics · 2023Pooled it
- Pharmacodynamic biomarkers for quantifying the mycobacterial effect of high doses of rifampin in patients with rifampin-susceptible pulmonary tuberculosis.International journal of mycobacteriologyTrial
- Future Prospects for Using Clinical Phenotypes in Tuberculosis Precision Medicine-An Approach for Clinical Management.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Review
- Single Saliva Sample Model-Informed Precision Dosing of Levofloxacin for Multidrug-Resistant Tuberculosis.Clinical pharmacokinetics · 2026Article
- Therapeutic Drug Monitoring for Improving Tuberculosis Treatment Outcomes: A Scoping Review of Clinical Studies.Clinical pharmacokinetics · 2026Article
- Therapeutic Drug Monitoring and Point-of-Care Technologies: Opportunities and Current Challenges.Therapeutic drug monitoring · 2026Review
- The effect of pregnancy on the population pharmacokinetics of levofloxacin in South Africans with rifampicin-resistant tuberculosis.Antimicrobial agents and chemotherapy · 2025Article
- A Call to Action: Empowering Pharmacists in Drug-Resistant Tuberculosis Management.Journal of multidisciplinary healthcare · 2025Review
- State of the art of real-life concentration monitoring of rifampicin and its implementation contextualized in resource-limited settings: the Tanzanian case.JAC-antimicrobial resistance · 2024Review
- Salivary Therapeutic Drug Monitoring of Antimicrobial Therapy: Feasible or Futile?Clinical pharmacokinetics · 2024Article
- Infant Exposure to Antituberculosis Drugs via Breast Milk and Assessment of Potential Adverse Effects in Breastfed Infants: Critical Review of Data.Pharmaceutics · 2023Review
- Pharmacokinetic-Pharmacodynamic Determinants of Clinical Outcomes for Rifampin-Resistant Tuberculosis: A Multisite Prospective Cohort Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Clinical standards for drug-susceptible pulmonary TB.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2022Article
- Clinical standards for the dosing and management of TB drugs.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2022Article
- Clinical Efficacy and Safety Analysis of Levofloxacin for the Prevention of Infection after Traumatic Osteoarthrosis and Internal Fixation: Systematic Review and Meta-Analysis.Emergency medicine international · 2022Article
- Population Pharmacokinetics of Levofloxacin and Moxifloxacin, and the Probability of Target Attainment in Ethiopian Patients with Multidrug-Resistant Tuberculosis.Infection and drug resistance · 2022Article
Corrections and comments
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Authors and funding
12 authors at 5 institutions in 4 countries.
Funding
Abstract
backgroundEarly detection and correction of low fluoroquinolone exposure may improve treatment of MDR-TB.
objectivesTo explore a recently developed portable, battery-powered, UV spectrophotometer for measuring levofloxacin in saliva of people treated for MDR-TB.
methodsPatients treated with levofloxacin as part of a regimen for MDR-TB in Northern Tanzania had serum and saliva collected concurrently at 1 and 4 h after 2 weeks of observed levofloxacin administration. Saliva levofloxacin concentrations were quantified in the field via spectrophotometry, while serum was analysed at a regional laboratory using HPLC. A Bayesian population pharmacokinetics model was used to estimate the area under the concentration-time curve (AUC0-24). Subtarget exposures of levofloxacin were defined by serum AUC0-24 <80 mg·h/L. The study was registered at Clinicaltrials.gov with clinical trial identifier NCT04124055.
resultsAmong 45 patients, 11 (25.6%) were women and 16 (37.2%) were living with HIV. Median AUC0-24 in serum was 140 (IQR = 102.4-179.09) mg·h/L and median AUC0-24 in saliva was 97.10 (IQR = 74.80-121.10) mg·h/L. A positive linear correlation was observed with serum and saliva AUC0-24, and a receiver operating characteristic curve constructed to detect serum AUC0-24 below 80 mg·h/L demonstrated excellent prediction [AUC 0.80 (95% CI = 0.62-0.94)]. Utilizing a saliva AUC0-24 cut-off of 91.6 mg·h/L, the assay was 88.9% sensitive and 69.4% specific in detecting subtarget serum AUC0-24 values, including identifying eight of nine patients below target.
conclusionsPortable UV spectrophotometry as a point-of-care screen for subtarget levofloxacin exposure was feasible. Use for triage to other investigation or personalized dosing strategy should be tested in a randomized study.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.