Evidence map›Paper›PMID 16304166›Full record

ArticleAntimicrobial agents and chemotherapy2005

Absolute bioavailability and intracellular pharmacokinetics of azithromycin in patients with cystic fibrosis.

Paul Beringer, Kitty My Tu Huynh, Jane Kriengkauykiat, Luke Bi, Nils Hoem, Stan Louie, Emily Han, Thao Nguyen, Donald Hsu, Purush A Rao and 2 more

Abstract readControlled Clinical Trial
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Macrolide antibiotics (including azithromycin) for cystic fibrosis.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Pooled it
  3. Macrolide antibiotics for cystic fibrosis.The Cochrane database of systematic reviews · 2012
    Pooled it
  4. Trial
  5. Impact of azithromycin on the clinical and antimicrobial effectiveness of tobramycin in the treatment of cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2017
    Trial
  6. Trial
  7. Trial
  8. Review
  9. Article
  10. Review
  11. Article
  12. Pharmacokinetics of oral antimycobacterials and dosing guidance for Mycobacterium avium complex treatment in cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021
    Article
  13. Review
  14. CFTR Modulators: Does One Dose Fit All?Journal of personalized medicine · 2021
    Review
  15. Review
  16. Azithromycin Exhibits Activity AgainstFrontiers in microbiology · 2021
    Article
  17. Article
  18. Article
  19. Prescribing azithromycin.Australian prescriber · 2015
    Review
  20. Article
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

12 authors.

Paul BeringerUniversity of Southern California, School of Pharmacy, 1985 Zonal Ave., Los Angeles, California 90033, USA. beringer@usc.edu
Kitty My Tu Huynh
Jane Kriengkauykiat
Luke Bi
Nils Hoem
Stan Louie
Emily Han
Thao Nguyen
Donald Hsu
Purush A Rao
Bertrand Shapiro
Mark Gill

Funding

ZOPOLRESTAT IN NORMOTENSIVE, TYPE 1 DIA WITH INCIPIENT NEPHROPATHYM01RR000043 · NCRR · UNIVERSITY OF SOUTHERN CALIFORNIA · PI ZAIA, JOHN A · 1985 to 2010
$76.4M
NCRR NIH HHS M01 RR000043NCRR NIH HHS M01-RR-00043
6 · The paper itself

Abstract

Chronic pulmonary infections with Pseudomonas aeruginosa are the primary cause of morbidity and mortality in patients with cystic fibrosis (CF). The macrolide antibiotics exhibit immunomodulatory and antivirulence activity. Clinical trials with azithromycin in CF have demonstrated significant improvements in pulmonary function and decreased hospitalizations. The purpose of this study was to compare the pharmacokinetics (PK) of azithromycin in patients with CF and controls. The study was conducted as an open-label, parallel, two-period crossover study involving 12 healthy volunteers and 12 patients with CF. Period 1 examined the serum PK following a single oral and intravenous dose, while period 2 examined the intracellular PK following multiple-dose oral administration. CF subjects differed significantly from controls based on weight (53.1 versus 71.0 kg; P < 0.01) and body mass index (19.7 versus 23.2; P < 0.01), respectively. Ninety-two percent of CF patients were pancreatic insufficient and were receiving pancreatic enzymes. The rate (time to reach maximum serum drug concentration, 3.0 versus 3.0 h; P = 0.78) and extent of absorption (absolute bioavailability, 34.2 versus 42.8%; P = 0.37) were similar in patients with CF and controls, respectively. Distribution to the tissues (rate of drug transfer from the central to the peripheral compartment, 1.22 versus 0.759 h(-1); P = 0.03) and elimination (rate of elimination from the central compartment, 0.693 versus 0.492 h(-1); P < 0.01) were more rapid in the healthy volunteers than in the CF subjects, respectively. Mononuclear cell concentrations (15.2 +/- 6.0 mg/liter) far exceeded the maximum serum drug concentration ( approximately 50-fold), demonstrating significant intracellular accumulation. These results indicate no alteration in dosage of azithromycin is necessary in patients with CF taking pancreatic enzymes.

Indexed as

AdultAzithromycinBiological AvailabilityCross-Over StudiesCystic FibrosisHumansPancreasAzithromycin

Identifiers

PMID16304166
PMCPMC1315964

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.