Trial · NCT00662012
Sodium Stibogluconate Treatment of Leishmaniasis
NCT00662012, Phase 2, Completed, U.S. Army Medical Research and Development Command; results first posted 2017-03-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sodium Stibogluconate Treatment of Leishmaniasis. Trials, record NCT00662012. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00662012
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sodium Stibogluconate Treatment of Leishmaniasis
- NCT number
- NCT00662012
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 414 participants, actual
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Conditions
- Leishmaniasis
- Interventions
- Sodium Stibogluconate (SSG)
- First posted
- 2008-04-21
- Last updated
- 2021-02-12
- Results first posted
- 2017-03-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Safety Endpoint - Frequency of Complications of Therapy | 5 years | The primary safety endpoint is the frequency of complications of therapy |
| Secondary | Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions . | 5 years | Improvement of lesions for cutaneous leishmanias, resolution of fever and lab abnormalities for visceral leishmaniasis and regression of mucosal lesions for mucocutaneous disease. |
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 | The Primary Safety Endpoint - Frequency of Complications of Therapy | 5 years | Analysis was per protocol | participants | NUMBER |
| SECONDARY | Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions . | 5 years | Analysis per protocol | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Safety Endpoint - Frequency of Complications of Therapy | SSG 20 mg/kg | 414 | participants | ||
| Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions . | SSG 20 mg/kg | 414 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SSG 20 mg/kg | 414 | |
| Overall Study | COMPLETED | SSG 20 mg/kg | 327 | |
| Overall Study | NOT COMPLETED | SSG 20 mg/kg | 87 |
Source ClinicalTrials.gov
Adverse events195
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 | Anemia | Blood and lymphatic system disorders | SSG 20 mg/kg | 7 | 414 | 7 |
| other | Leukopenia | Blood and lymphatic system disorders | SSG 20 mg/kg | 21 | 414 | 21 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | SSG 20 mg/kg | 59 | 414 | 59 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | SSG 20 mg/kg | 10 | 414 | 10 |
| other | Bundle Branch Block Left | Cardiac disorders | SSG 20 mg/kg | 4 | 414 | 4 |
| other | Bundle Branch Block Right | Blood and lymphatic system disorders | SSG 20 mg/kg | 22 | 414 | 22 |
| other | Conduction Disorder | Cardiac disorders | SSG 20 mg/kg | 9 | 414 | 9 |
| other | Dilatation Atrial | Cardiac disorders | SSG 20 mg/kg | 8 | 414 | 8 |
| other | Palpitations | Cardiac disorders | SSG 20 mg/kg | 9 | 414 | 9 |
| other | Sinus Tachycardia | Cardiac disorders | SSG 20 mg/kg | 6 | 414 | 6 |
1 to 10 of 195Source ClinicalTrials.gov
See all 195 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SSG 20 mg/kg | ||
| Total, other adverse events | SSG 20 mg/kg | 414 | 414 |
| Total, serious adverse events | SSG 20 mg/kg | 17 | 414 |
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/NCT00662012
GET https://conductscience.org/api/trials/v1/NCT00662012/events?page=2