Trial · NCT00657618
Use of Sodium Stibogluconate as a Treatment for Leishmaniasis
NCT00657618, Phase 1, Phase 2, Completed, U.S. Army Medical Research and Development Command; results first posted 2018-02-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of Sodium Stibogluconate as a Treatment for Leishmaniasis. Trials, record NCT00657618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00657618
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Sodium Stibogluconate as a Treatment for Leishmaniasis
- NCT number
- NCT00657618
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Conditions
- Leishmaniasis
- Interventions
- Sodium Stibogluconate (SSG)
- First posted
- 2008-04-14
- Last updated
- 2020-01-02
- Results first posted
- 2018-02-27
- Limitations and caveats
- Due to low enrollment protocol was amended to remove efficacy objective and only collect safety data. No data entry or statistical analyses of patient data was conducted.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience | prior to infusion on days (± 2) 5, 10, 15, 20, 25, and 28 | The safety of Pentostam (SSG) treatment was evaluated through the daily assessment of AEs during treatment. Additionally, clinical laboratory tests including serum chemistry (glucose, electrolytes, blood urea nitrogen \[BUN\], creatinine, alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], total bilirubin, alkaline phosphatase \[ALK\], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; electrocardiograms (ECGs); and physical examinations were performed at screening and prior to Pentostam infusion on Days (± 2) 5, 10, 15, 20, 25, and 28 (Days 25 and 28 for patients with visceral or mucocutaneous leishmaniasis only). At the completion of Pentostam treatment, patients were encouraged to arrange follow-up at 2, 6, and 12 months after treatment; however, follow-up was not required. |
| Primary | Number of Participants Experiencing Serious or Unexpected Adverse Events, by Type of Serious or Unexpected Adverse Events | prior to infusion on days 2) 5, 10, 15, 20, 25, and 28 | The safety of Pentostam (SSG) treatment was evaluated through the daily assessment of AEs during treatment. Additionally, clinical laboratory tests including serum chemistry (glucose, electrolytes, blood urea nitrogen \[BUN\], creatinine, alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], total bilirubin, alkaline phosphatase \[ALK\], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; electrocardiograms (ECGs); and physical examinations were performed at screening and prior to Pentostam infusion on Days (± 2) 5, 10, 15, 20, 25, and 28 (Days 25 and 28 for patients with visceral or mucocutaneous leishmaniasis only). At the completion of Pentostam treatment, patients were encouraged to arrange follow-up at 2, 6, and 12 months after treatment; however, follow-up was not required. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience | prior to infusion on days (± 2) 5, 10, 15, 20, 25, and 28 | 74 patients received at least one dose of IV pentostam | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Serious or Unexpected Adverse Events, by Type of Serious or Unexpected Adverse Events | prior to infusion on days 2) 5, 10, 15, 20, 25, and 28 | 74 patients received at least one dose of IV pentostam | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience | Treatment Only | Myalgia/arthralgia | 12 | Participants | |
| Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience | Treatment Only | Elevated liver-associated enzymes | 10 | Participants | |
| Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience | Treatment Only | Rash | 3 | Participants | |
| Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience | Treatment Only | Subtle elevation of amylase and lipase | 1 | Participants | |
| Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience | Treatment Only | Misdiagnosis | 1 | Participants | |
| Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience | Treatment Only | Decreased white blood cell count | 1 | Participants | |
| Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience | Treatment Only | Nephrotoxicity | 1 | Participants | |
| Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience | Treatment Only | Chemical pancresatitis | 1 | Participants | |
| Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience | Treatment Only | Drug reaction | 1 | Participants | |
| Number of Participants Experiencing Serious or Unexpected Adverse Events, by Type of Serious or Unexpected Adverse Events | Treatment Only | Elevated lipase level | 4 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sodium Stibogluconate (SSG) | 77 | |
| Overall Study | COMPLETED | Sodium Stibogluconate (SSG) | 34 | |
| Overall Study | NOT COMPLETED | Sodium Stibogluconate (SSG) | 43 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Myalgia/arthralgia | Musculoskeletal and connective tissue disorders | Treatment Only | 12 | 74 | 12 |
| other | Elevated liver-assocated enzymes | Investigations | Treatment Only | 10 | 74 | 10 |
| other | Rash | Immune system disorders | Treatment Only | 3 | 74 | 3 |
| other | Subtle ECG changes | Investigations | Treatment Only | 1 | 74 | 1 |
| other | Elevation of amylase and lipase | Investigations | Treatment Only | 1 | 74 | 1 |
| other | Misdiagnosis | Investigations | Treatment Only | 1 | 74 | 1 |
| other | Decreased white blood cell count | Investigations | Treatment Only | 1 | 74 | 1 |
| other | Nephrotoxicity | Investigations | Treatment Only | 1 | 74 | 1 |
| other | Chemical pancreatitis | Gastrointestinal disorders | Treatment Only | 1 | 74 | 1 |
| other | Drug reaction | General disorders | Treatment Only | 1 | 74 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Only | 0 | 74 |
| Total, other adverse events | Treatment Only | 32 | 74 |
| Total, serious adverse events | Treatment Only | 8 | 74 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00657618
GET https://conductscience.org/api/trials/v1/NCT00657618/registered