Evidence map›Paper›PMID 18267006›Full record

Trial reportBMC infectious diseases2008

Adjuvant interferon gamma in patients with pulmonary atypical Mycobacteriosis: a randomized, double-blind, placebo-controlled study.

María T Milanés-Virelles, Idrian García-García, Yamilet Santos-Herrera, Magalys Valdés-Quintana, Carmen M Valenzuela-Silva, Gaspar Jiménez-Madrigal, Thelvia I Ramos-Gómez, Iraldo Bello-Rivero, Norma Fernández-Olivera, Reinaldo B Sánchez-de la Osa and 5 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 11% 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

36 citing papers in PubMed, 1 synthesis or guideline pooled it, 72 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Case report: co-infection ofAME case reports · 2025
    Article
  7. Growing from common ground: nontuberculous mycobacteria and bronchiectasis.European respiratory review : an official journal of the European Respiratory Society · 2024
    Review
  8. Review
  9. Review
  10. Review
  11. Open forum infectious diseases · 2022
    Review
  12. Article
  13. Review
  14. Management ofEuropean respiratory review : an official journal of the European Respiratory Society · 2022
    Review
  15. Article
  16. Approach to the diagnosis and treatment of non-tuberculous mycobacterial disease.Journal of clinical tuberculosis and other mycobacterial diseases · 2021
    Article
  17. Review
  18. Article
  19. Pulmonary non-tuberculous mycobacterial infections: current state and future management.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2020
    Review
  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

15 authors at 4 institutions in 2 countries.

María T Milanés-VirellesCenter for Biological Research, Clinical Trials Division, Havana, Cuba. mariateresam@infomed.sld.cu
Idrian García-García
Yamilet Santos-Herrera
Magalys Valdés-Quintana
Carmen M Valenzuela-Silva
Gaspar Jiménez-Madrigal
Thelvia I Ramos-Gómez
Iraldo Bello-Rivero
Norma Fernández-Olivera
Reinaldo B Sánchez-de la Osa
Carmen Rodríguez-Acosta
Lidia González-Méndez
Gregorio Martínez-Sánchez
Pedro A López-Saura
MACGAM Study Group
Cuban Neuroscience Center · CUHospital Oncológico Docente "Conrado Benítez García" · CUMirai Hospital · JPUniversity of Havana · CU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHigh antibiotic resistance is described in atypical Mycobacteriosis, mainly by Mycobacterium avium complex (MAC).

methodsA randomized, double-blind, placebo-controlled clinical trial was carried out in two hospitals to evaluate the effect of interferon (IFN) gamma as immunoadjuvant to chemotherapy on patients with atypical mycobacteria lung disease. Patients received placebo or 1 x 106 IU recombinant human IFN gamma intramuscularly, daily for one month and then three times per week up to 6 months as adjuvant to daily oral azithromycin, ciprofloxacin, ethambutol and rifampin. Sputum samples collection for direct smear observation and culture as well as clinical and thorax radiography assessments were done during treatment and one year after. Cytokines and oxidative stress determinations were carried out in peripheral blood before and after treatment.

resultsEighteen patients were included in the IFN group and 14 received placebo. Groups were homogeneous at entry; average age was 60 years, 75% men, 84% white; MAC infection prevailed (94%). At the end of treatment, 72% of patients treated with IFN gamma were evaluated as complete responders, but only 36% in the placebo group. The difference was maintained during follow-up. A more rapid complete response was obtained in the IFN group (5 months before), with a significantly earlier improvement in respiratory symptoms and pulmonary lesions reduction. Disease-related deaths were 35.7% of the patients in the placebo group and only 11.1% in the IFN group. Three patients in the IFN group normalized their globular sedimentation rate values. Although differences in bacteriology were not significant during the treatment period, some patients in the placebo group converted again to positive during follow-up. Significant increments in serum TGF-beta and advanced oxidation protein products were observed in the placebo group but not among IFN receiving patients. Treatments were well tolerated. Flu-like symptoms predominated in the IFN gamma group. No severe events were recorded.

conclusionThese data suggest that IFN gamma is useful and well tolerated as adjuvant therapy in patients with pulmonary atypical Mycobacteriosis, predominantly MAC. Further wider clinical trials are encouraged.

trial registrationCurrent Controlled Trials ISRCTN70900209.

Indexed as

Adjuvants, ImmunologicAgedCubaCytokinesDouble-Blind MethodDrug TherapyFemaleHumansInterferon-gammaLungMaleMiddle AgedMycobacterium avium ComplexMycobacterium Infections, NontuberculousOxidative StressRecombinant ProteinsAdjuvants, ImmunologicCytokinesInterferon-gammaRecombinant Proteins

Identifiers

PMID18267006
PMCPMC2275277
OpenAlexW2024905179

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.