Evidence map›Paper›PMID 29170074›Full record

ArticleContemporary clinical trials2018

Study design considerations for the Standardized Treatment of Pulmonary Exacerbations 2 (STOP2): A trial to compare intravenous antibiotic treatment durations in CF.

Sonya L Heltshe, Natalie E West, Donald R VanDevanter, D B Sanders, Valeria V Beckett, Patrick A Flume, Christopher H Goss, STOP Study Group

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 4 pooled it
5.1field-weighted citation impact, top 4% 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.

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

28 citing papers in PubMed, 4 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Duration of intravenous antibiotic therapy in people with cystic fibrosis.The Cochrane database of systematic reviews · 2019
    Pooled it
  5. Correlates of FEV₁ deficit in pulmonary exacerbations of cystic fibrosis and associated clinical outcomes.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2026
    Trial
  6. Trial
  7. Characteristics associated with cystic fibrosis-related pulmonary exacerbation treatment location.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2024
    Trial
  8. Association of site of treatment with clinical outcomes following intravenous antimicrobial treatment of a pulmonary exacerbation.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2022
    Trial
  9. Health care costs in a randomized trial of antimicrobial duration among cystic fibrosis patients with pulmonary exacerbations.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2022
    Trial
  10. C-reactive protein (CRP) as a biomarker of pulmonary exacerbation presentation and treatment response.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2022
    Trial
  11. Health care costs related to home spirometry in the eICE randomized trial.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2022
    Trial
  12. Trial
  13. Article
  14. Diagnosis and Management of Cystic Fibrosis Exacerbations.Seminars in respiratory and critical care medicine · 2023
    Review
  15. Article
  16. Two Steps Forward: Improving the Management of Cystic Fibrosis Pulmonary Exacerbations.American journal of respiratory and critical care medicine · 2021
    Article
  17. Outcomes of cystic fibrosis pulmonary exacerbations treated with antibiotics with activity against anaerobic bacteria.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021
    Article
  18. Review
  19. Pseudomonas aeruginosa antimicrobial susceptibility test (AST) results and pulmonary exacerbation treatment responses in cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021
    Article
  20. Review
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

8 authors at 5 institutions in 1 country.

Sonya L HeltsheCFF Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA 98121, USA; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA 98195, USA. Electronic address: sonya.heltshe@seattlechildrens.org.
Natalie E WestDivision of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.
Donald R VanDevanterCase Western Reserve University School of Medicine, Cleveland, OH 44106, USA.
D B SandersDepartment of Pediatrics, Riley Hospital for Children, School of Medicine, Indiana University, Indiana, IN 46202, USA.
Valeria V BeckettCFF Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA 98121, USA.
Patrick A FlumeDepartments of Medicine and Pediatrics, Medical University of South Carolina, Charleston, SC 29425, USA.
Christopher H GossCFF Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA 98121, USA; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA 98195, USA; Division of Pulmonary Medicine, Department of Medicine, University of Washington School of Medicine, Seattle, WA 98121, USA.
STOP Study Group
University of Washington · USJohns Hopkins University · USMedical University of South Carolina · USRiley Hospital for Children · USUniversity School · US

Funding

South Carolina Clinical & Translational Research Institute (SCTR)UL1TR001450 · NCATS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T., FLUME, PATRICK A · 2015 to 2024
$41.1M
Translational Research Center to Expedite Novel Therapies in Cystic FibrosisP30DK089507 · NIDDK · SEATTLE CHILDREN'S HOSPITAL · PI Christopher Hooper Goss, Lucas R Hoffman · 2010 to 2026
$21.4M
South Carolina Clinical & Translational Research Institute (SCTR)UL1TR000062 · NCATS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2012 to 2014
$9.4M
NCATS NIH HHS UL1 TR000062NCATS NIH HHS UL1 TR001450NIDDK NIH HHS P30 DK089507
6 · The paper itself

Abstract

backgroundPulmonary exacerbations (PEx) in cystic fibrosis (CF) are common and contribute to morbidity and mortality. Duration of IV antibiotic therapy to treat PEx varies widely in the US, and there are few data to guide treatment decisions.

methodsWe combined a survey of CF stakeholders with retrospective analyses of a recent observational study of CF PEx to design a multicenter, randomized, prospective study comparing the efficacy and safety of different durations of IV antibiotics for PEx to meet the needs of people with CF and their caregivers.

resultsIV antibiotic duration was cited as the most important PEx research question by responding CF physicians and top concern among surveyed CF patients/caregivers. During PEx, forced expiratory volume in 1s (FEV

conclusionsA divergent trial design that evaluates subjects' interim improvement in FEV

Indexed as

Anti-Bacterial AgentsCystic FibrosisAdministration, IntravenousDrug Administration ScheduleFemaleHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicResearch DesignRespiratory Function TestsTime FactorsAnti-Bacterial AgentsCystic fibrosisFEV1Pulmonary exacerbationSymptoms

Identifiers

PMID29170074
PMCPMC5742044
OpenAlexW2768888132

What OpenQuestion holds

Textmetadata
LicenceTDM
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.