Evidence map›Paper›PMID 23857024›Full record

Trial reportThe American journal of tropical medicine and hygiene2013

Randomized, double-blinded, phase 2 trial of WR 279,396 (paromomycin and gentamicin) for cutaneous leishmaniasis in Panama.

Néstor Sosa, Zeuz Capitán, Javier Nieto, Melissa Nieto, José Calzada, Hector Paz, Carmenza Spadafora, Mara Kreishman-Deitrick, Karen Kopydlowski, Diane Ullman and 5 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The American journal of tropical medicine and hygiene, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 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

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Interventions for American cutaneous and mucocutaneous leishmaniasis.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Pooled it
  3. Topical paromomycin for New World cutaneous leishmaniasis.PLoS neglected tropical diseases · 2019
    Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Review
  9. Observational
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. An update on pharmacotherapy for leishmaniasis.Expert opinion on pharmacotherapy · 2015
    Review
  18. Article
  19. Review
  20. In response.The American journal of tropical medicine and hygiene · 2014
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Néstor Sosa
Zeuz Capitán
Javier Nieto
Melissa Nieto
José Calzada
Hector Paz
Carmenza Spadafora
Mara Kreishman-Deitrick
Karen Kopydlowski
Diane Ullman
William F McCarthy
Janet Ransom
Jonathan Berman
Charles Scott
Max Grogl

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this randomized, double-blinded Phase 2 trial, 30 patients with Leishmania panamensis cutaneous leishmaniasis were randomly allocated (1:1) to receive once daily topical treatment with WR 279,396 (15% paromomycin + 0.5% gentamicin) or Paromomycin Alone (15% paromomycin) for 20 days. The index lesion cure rate after 6 months follow-up was 13 of 15 (87%) for WR 279,396 and 9 of 15 (60%) for Paromomycin Alone (P = 0.099). When all treated lesions were included, the final cure rate for WR 279,398-treated patients was again 87%, but the final cure rate for Paromomycin Alone-treated patients was 8 of 15 (53.3%; P = 0.046). Both creams were well tolerated with mild application site reactions being the most frequent adverse event. The increased final cure rate in the WR 279,396 group in this small Phase 2 study suggests that the combination product may provide greater clinical benefit than paromomycin monotherapy against L. panamensis cutaneous leishmaniasis.

Indexed as

Administration, CutaneousAdolescentChildChild, PreschoolDouble-Blind MethodDrug Therapy, CombinationEndpoint DeterminationFemaleGentamicinsHumansLeishmaniasis, CutaneousMalePanamaParomomycinGentamicinsParomomycin

Identifiers

PMID23857024
PMCPMC3771300

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.