Evidence map›Paper›PMID 18070980›Full record

Trial reportAntimicrobial agents and chemotherapy2008

Population pharmacokinetics of levofloxacin, gatifloxacin, and moxifloxacin in adults with pulmonary tuberculosis.

Charles A Peloquin, David Jamil Hadad, Lucilia Pereira Dutra Molino, Moises Palaci, W Henry Boom, Reynaldo Dietze, John L Johnson

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00396084 (Randomized, Open Label, Multiple Dose Phase I Study of the Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, and Moxifloxacin in HIV-non-infected Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis), which is not on this map. Cited by 99 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 4 pooled it
5.1field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT00396084 phase1 / phase2completednot on this map

Randomized, Open Label, Multiple Dose Phase I Study of the Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, and Moxifloxacin in HIV-non-infected Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2004 to 2007Enrolled70ConditionsTuberculosisArmsGatifloxacin, Isoniazid, Levofloxacin, Linezolid, Moxifloxacin
3 · Its place in the literature

Who cites it

99 citing papers in PubMed, 4 syntheses or guidelines pooled it, 187 citations in OpenAlex.

  1. Pooled it
  2. Treatment of Drug-Resistant Tuberculosis. An Official ATS/CDC/ERS/IDSA Clinical Practice Guideline.American journal of respiratory and critical care medicine · 2019
    Guideline
  3. Pooled it
  4. Fluoroquinolones for treating tuberculosis (presumed drug-sensitive).The Cochrane database of systematic reviews · 2013
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39 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Charles A PeloquinInfectious Disease Pharmacokinetics Laboratory, National Jewish Medical and Research Center, Denver, CO 80206, USA. peloquinc@njc.org
David Jamil Hadad
Lucilia Pereira Dutra Molino
Moises Palaci
W Henry Boom
Reynaldo Dietze
John L Johnson
Universidade Federal do Espírito Santo · BRNational Jewish Health · USUniversity Hospitals Case Medical Center · USUniversity School · US

Funding

Tuberculosis Prevention Research Unit /TBRU/-266095383N01AI095383 · NIAID · CASE WESTERN RESERVE UNIVERSITY · 2000 to 2005
$5.6M
NIAID NIH HHS N01 AI070022NIAID NIH HHS N01 AI095383NIAID NIH HHS N01-AI70022NIAID NIH HHS N01-AI95383
6 · The paper itself

Abstract

The objective of this study was to determine the population pharmacokinetic parameters of levofloxacin, gatifloxacin, and moxifloxacin following multiple oral doses. Twenty-nine patients with tuberculosis at the University Hospital in Vitória, Brazil, participated. Subjects received multiple doses of one drug (levofloxacin, 1,000 mg daily, or gatifloxacin or moxifloxacin, 400 mg daily) as part of a 7-day study of early bactericidal activity. Serum samples were collected over 24 h after the fifth dose and assayed using validated high-performance liquid chromatography assays. Concentration-time data were analyzed using noncompartmental, compartmental, and population methods. The three drugs were well tolerated. Levofloxacin produced the highest maximum plasma concentrations (median, 15.55 microg/ml; gatifloxacin, 4.75 microg/ml; moxifloxacin, 6.13 microg/ml), largest volume of distribution (median, 81 liters; gatifloxacin, 79 liters; moxifloxacin, 63 liters), and longest elimination half-life (median, 7.4 h; gatifloxacin, 5.0 h; moxifloxacin, 6.5 h). A one-compartment model, with or without weight as a covariate, adequately described the data. Postmodeling simulations using median population parameter estimates closely approximated the median values from the original data. Area under the concentration-time curve/MIC ratios for free drug were high. All three quinolones showed favorable pharmacokinetic and pharmacodynamic indices, with the most favorable results in this population being seen with levofloxacin at the comparative doses used.

Indexed as

LevofloxacinAdolescentAdultAnti-Bacterial AgentsArea Under CurveAza CompoundsBrazilFemaleFluoroquinolonesGatifloxacinHumansMaleMicrobial Sensitivity TestsMiddle AgedMoxifloxacinMycobacterium tuberculosisAnti-Bacterial AgentsAza CompoundsFluoroquinolonesGatifloxacinLevofloxacinMoxifloxacinOfloxacinQuinolines

Identifiers

PMID18070980
PMCPMC2258503
OpenAlexW2124584779

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.