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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 Materiel 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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
77 total patients, 74 treated, 34 completed treatment, 43 withdrawals

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Sodium Stibogluconate (SSG)

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.


Participant Flow:   Overall Study
    Sodium Stibogluconate (SSG)
STARTED   77 
COMPLETED   34 
NOT COMPLETED   43 
Adverse Event                32 
Withdrawal by Subject                8 
negative for leishmaniasis                2 
didn't start due to schedule conflicts                1 



  Baseline Characteristics

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.
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.

Reporting Groups
  Description
Sodium Stibogluconate (SSG)

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.


Baseline Measures
   Sodium Stibogluconate (SSG) 
Overall Participants Analyzed 
[Units: Participants]
 77 
Age, Customized [1] [2] 
[Units: Participants]
  
[1] 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] Data was not collected
Sex/Gender, Customized [1] [2] 
[Units: Participants]
  
[1] 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] Data not collected
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed   77 
United States   77 


  Outcome Measures

1.  Primary:   Number of Participants That Discontinued Due to Adverse Experience, by Type of Adverse Experience   [ Time Frame: prior to infusion on days (± 2) 5, 10, 15, 20, 25, and 28 ]

2.  Primary:   Number of Participants Experiencing Serious or Unexpected Adverse Events, by Type of Serious or Unexpected Adverse Events   [ Time Frame: prior to infusion on days 2) 5, 10, 15, 20, 25, and 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
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.


  More Information

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
e-mail: rose.resnner@us.armyh.mil



Responsible Party: U.S. Army Medical Research and Materiel 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