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Sodium Stibogluconate Treatment of Leishmaniasis

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00662012
First received: April 15, 2008
Last updated: January 18, 2017
Last verified: November 2016
Results First Received: September 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leishmaniasis
Intervention: Drug: Sodium Stibogluconate (SSG)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment commenced on 11May2002 with follow-up periods ranging from 12 to 24 months after completion of treatment. Treatment was received at Walter Reed Army Medical Center, Washington, DC, USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SSG 20 mg/kg

All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with 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 for less responsive; 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.


Participant Flow:   Overall Study
    SSG 20 mg/kg
STARTED   414 
COMPLETED   327 
NOT COMPLETED   87 
Lost to Follow-up                85 
Death                1 
Withdrawal by Subject                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat, evaluable, and safety populations included all patients who received at least 1 dose of SSG. Data were displayed by regimen and overall for patients with CL.

Reporting Groups
  Description
SSG 20 mg/kg

All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with 20 mg/kg once daily intravenously with 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 for less responsive; 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.


Baseline Measures
   SSG 20 mg/kg 
Overall Participants Analyzed 
[Units: Participants]
 414 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.1  (7.96) 
Gender 
[Units: Participants]
Count of Participants
 
Female      9   2.2% 
Male      405  97.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      7   1.7% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      62  15.0% 
White      295  71.3% 
More than one race      0   0.0% 
Unknown or Not Reported      50  12.1% 
Region of Enrollment [1] 
[Units: Participants]
 
United States   414 
[1] All subjects must be willing to locate to the WRAMC area during treatment
Lesion data - Duration since onset 
[Units: Days]
Mean (Standard Deviation)
 111.6  (47.62) 
Lesion data - Number of lesions [1] 
[Units: Lesions]
Mean (Standard Deviation)
 5.0  (5.04) 
[1] Number of lesions on body


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Primary Safety Endpoint - Frequency of Complications of Therapy   [ Time Frame: 5 years ]

2.  Secondary:   Improvement of Lesions, Resolution of Fever and Lab Abnormalities for Visceral Leishmaniasis and Regression of Mucosal Lesions .   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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: Naomi Aronson, MD
Organization: Uniformed Services University of Health Sciences (USUHS)
phone: (301) 295-3621
e-mail: naomi.e.aronson.civ@mail.mil



Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00662012     History of Changes
Other Study ID Numbers: A-10950
WU#01-19002 ( Other Identifier: WRAIR )
Study First Received: April 15, 2008
Results First Received: September 28, 2016
Last Updated: January 18, 2017