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Use of Sodium Stibogluconate as a Treatment for Leishmaniasis

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ClinicalTrials.gov Identifier: NCT00657618
Recruitment Status : Completed
First Posted : April 14, 2008
Results First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leishmaniasis
Intervention Drug: Sodium Stibogluconate (SSG)
Enrollment 77
Recruitment Details 77 total patients, 74 treated, 34 completed treatment, 43 withdrawals
Pre-assignment Details 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.
Arm/Group Title Sodium Stibogluconate (SSG)
Hide Arm/Group Description

All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).

Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.

Period Title: Overall Study
Started 77
Completed 34
Not Completed 43
Reason Not Completed
Adverse Event             32
Withdrawal by Subject             8
negative for leishmaniasis             2
didn't start due to schedule conflicts             1
Arm/Group Title Sodium Stibogluconate (SSG)
Hide Arm/Group Description

All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).

Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.

Overall Number of Baseline Participants 77
Hide Baseline Analysis Population Description
Due to low enrollment the protocol was amended to remove efficacy objective and only collect safety data for subjects. No data entry or statistical analyses of patient data was conducted.
Age, Customized   [1] [2] 
Measure Type: Number
Unit of measure:  Participants
>=18 years and <=65 years Number Analyzed 0 participants
[1]
Measure Description: Due to low enrollment the protocol was amended to remove efficacy objective and only collect safety data for subjects. No data entry or statistical analyses of patient data including age data was conducted.
[2]
Measure Analysis Population Description: Data was not collected
Sex/Gender, Customized   [1] [2] 
Measure Type: Number
Unit of measure:  Participants
Male and Female Number Analyzed 0 participants
[1]
Measure Description: Due to low enrollment the protocol was amended to remove efficacy objective and only collect safety data for subjects. No data entry or statistical analyses of patient data including gender data was conducted.
[2]
Measure Analysis Population Description: Data not collected
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 77 participants
77
1.Primary Outcome
Title Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience
Hide Description 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.
Time Frame prior to infusion on days (± 2) 5, 10, 15, 20, 25, and 28
Hide Outcome Measure Data
Hide Analysis Population Description
74 patients received at least one dose of IV pentostam
Arm/Group Title Treatment Only
Hide Arm/Group Description:

All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).

Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.

Overall Number of Participants Analyzed 74
Measure Type: Count of Participants
Unit of Measure: Participants
Myalgia/arthralgia
12
  16.2%
Elevated liver-associated enzymes
10
  13.5%
Rash
3
   4.1%
Subtle elevation of amylase and lipase
1
   1.4%
Misdiagnosis
1
   1.4%
Decreased white blood cell count
1
   1.4%
Nephrotoxicity
1
   1.4%
Chemical pancresatitis
1
   1.4%
Drug reaction
1
   1.4%
2.Primary Outcome
Title Number of Participants Experiencing Serious or Unexpected Adverse Events, by Type of Serious or Unexpected Adverse Events
Hide Description 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.
Time Frame prior to infusion on days 2) 5, 10, 15, 20, 25, and 28
Hide Outcome Measure Data
Hide Analysis Population Description
74 patients received at least one dose of IV pentostam
Arm/Group Title Treatment Only
Hide Arm/Group Description:

All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).

Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.

Overall Number of Participants Analyzed 74
Measure Type: Count of Participants
Unit of Measure: Participants
Elevated lipase level
4
   5.4%
Chemical hepatitis
1
   1.4%
Allergic reaction with atypical presentation
1
   1.4%
Misdiagnosis
1
   1.4%
Allergic reaction
1
   1.4%
Hospitalized for unhealed cutaneous lesion
1
   1.4%
Time Frame prior to infusion on days (± 2) 5, 10, 15, 20, 25, and 28
Adverse Event Reporting Description Safety of Pentostam was evaluated through daily assessment of AEs. Clinical lab tests including serum chemistry (glucose, electrolytes, blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase], total bilirubin, alkaline phosphatase], amylase, and lipase) and hematology (hemoglobin, hematocrit, platelets, and white blood cells with differential); vital signs measurements; electrocardiograms); and physical examinations were performed at screening and prior to infusion
 
Arm/Group Title Treatment Only
Hide Arm/Group Description

All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).

Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.

All-Cause Mortality
Treatment Only
Affected / at Risk (%)
Total   0/74 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Only
Affected / at Risk (%) # Events
Total   8/74 (10.81%)    
Immune system disorders   
Allergic reaction with atypical presentation  1  1/74 (1.35%)  1
Allergic reaction  1  1/74 (1.35%)  1
Investigations   
Elevated lipase/aysmpotmatic chemical pancreatitis  1  4/74 (5.41%)  4
Chemical hepatitis  1  1/74 (1.35%)  1
Misdiagnosis  1  1/74 (1.35%)  1
Product Issues   
Hospitalization for unhealed lesion  1  1/74 (1.35%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Only
Affected / at Risk (%) # Events
Total   32/74 (43.24%)    
Gastrointestinal disorders   
Chemical pancreatitis  1  1/74 (1.35%)  1
General disorders   
Drug reaction  1  1/74 (1.35%)  1
Immune system disorders   
Rash  1  3/74 (4.05%)  3
Investigations   
Elevated liver-assocated enzymes  1  10/74 (13.51%)  10
Subtle ECG changes  1  1/74 (1.35%)  1
Elevation of amylase and lipase  1  1/74 (1.35%)  1
Misdiagnosis  1  1/74 (1.35%)  1
Decreased white blood cell count  1  1/74 (1.35%)  1
Nephrotoxicity  1  1/74 (1.35%)  1
Musculoskeletal and connective tissue disorders   
Myalgia/arthralgia  1  12/74 (16.22%)  12
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Roseanne A. Resnner, MD
Organization: WRAIR
Phone: 301-295-6400
Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT00657618     History of Changes
Other Study ID Numbers: A-12631
WU#04-19011 ( Other Identifier: IRB )
Pentostam ( Registry Identifier: NCT00657618 )
First Submitted: April 8, 2008
First Posted: April 14, 2008
Results First Submitted: October 25, 2017
Results First Posted: February 27, 2018
Last Update Posted: February 27, 2018