Evidence map›Paper›PMID 32853648›Full record

ReviewChest2021

Development of Drugs for Nontuberculous Mycobacterial Disease: Clinicians' Interpretation of a US Food and Drug Administration Workshop.

Patrick A Flume, David E Griffith, James D Chalmers, Charles L Daley, Kenneth Olivier, Anne O'Donnell, Timothy Aksamit, Shannon Kasperbauer, Amy Leitman, Kevin L Winthrop

Open access · bronzeAbstract readReview
In one paragraph

Review in Chest, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. A systematic review of tetracyclines for nontuberculous mycobacteria: focus on rapidly growing mycobacteria.European respiratory review : an official journal of the European Respiratory Society · 2025
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. The Role of β-Lactam Antibiotics in Treating Mycobacterium abscessus: From Laboratory Insights to Clinical Applications and the Case for Clinical Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Review
  6. Article
  7. Article
  8. Core outcome domains forERJ open research · 2025
    Article
  9. Visualizing PulmonaryAmerican journal of respiratory and critical care medicine · 2025
    Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. 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

10 authors at 10 institutions in 2 countries.

Patrick A FlumeDepartments of Medicine and Pediatrics, Medical University of South Carolina, Charleston, SC. Electronic address: flumepa@musc.edu.
David E GriffithUniversity of Texas Health Science Center at Tyler, Tyler, TX.
James D ChalmersDivision of Molecular and Clinical Medicine, University of Dundee, Dundee, Scotland.
Charles L DaleyDepartment of Medicine, National Jewish Health and the University of Colorado, Denver, CO.
Kenneth OlivierLaboratory of Chronic Airway Infection, Pulmonary Branch, National Heart, Lung and Blood Institute/National Institutes of Health, Bethesda, MD.
Anne O'DonnellDivision of Pulmonary, Critical Care and Sleep Medicine, Georgetown University Medical Center, Washington, DC.
Timothy AksamitPulmonary Disease and Critical Care Medicine, Mayo Clinic, Rochester, MN.
Shannon KasperbauerDepartment of Medicine, National Jewish Health and the University of Colorado, Denver, CO.
Amy LeitmanNTM Info & Research, Coral Gables, FL.
Kevin L WinthropDivision of Infectious Disease, Oregon Health and Science University Schools of Public Health and Medicine, Portland, OR.
American Orchid Society · USGeorgetown University Medical Center · USMayo Clinic in Florida · USMedical University of South Carolina · USNational Heart Lung and Blood Institute · USNational Jewish Health · USOregon Health & Science University · USThe University of Texas Health Science Center at Tyler · USUniversity of Colorado Denver · USUniversity of Dundee · GB

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
Bronchiectasis and chronic airway infectionZIAHL006200 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI FENNELLY, KEVIN · 2015 to 2025
$25.1M
NCATS NIH HHS UL1 TR001450
6 · The paper itself

Abstract

The US Food and Drug Administration convened a workshop to discuss clinical trial design challenges and considerations related to the treatment of nontuberculous mycobacterial pulmonary disease, to include topics such as clinical trial end points, duration, and populations. The clinicians participating in the meeting provide here their interpretation of the discussion, which included US Food and Drug Administration and industry representatives. The treatment of nontuberculous mycobacterial pulmonary disease typically includes multiple antibiotics for a prolonged period and can be difficult to tolerate; there is a great need for new treatment options. Most individuals have a microbiologic response to therapy, but data correlating decreasing bacillary load with patient-reported outcomes or measured functional improvement are lacking. Accordingly, trial designs for new therapeutic agents should incorporate both microbiologic and clinical outcome measures and select appropriate study candidates with capacity for measurable change of such outcome measures. The need for shorter study designs, early primary end points, and placebo control arms was highlighted during the workshop.

Indexed as

Drug DevelopmentAnti-Bacterial AgentsClinical Trials as TopicCongresses as TopicHumansMycobacterium Infections, NontuberculousResearch DesignUnited StatesUnited States Food and Drug AdministrationAnti-Bacterial Agentsclinical trialsdrug developmentmycobacteria

Identifiers

PMID32853648
PMCPMC8039007
OpenAlexW3080589934

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.