Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treating Brain Swelling in Pediatric Cerebral Malaria (TBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03300648
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : August 16, 2018
Sponsor:
Collaborators:
Washington University School of Medicine
University of Maryland, College Park
Children's Research Institute
Information provided by (Responsible Party):
Terrie Taylor, Michigan State University

Brief Summary:
This study evaluates the effectiveness of two interventions in Malawian children with cerebral malaria at high risk of death. One-third of the participants will receive treatment as usual, one-third will receive treatment as usual and be placed on a mechanical ventilator, and one-third will receive treatment as usual plus intravenous hypertonic saline.

Condition or disease Intervention/treatment Phase
Malaria, Cerebral Other: Mechanical ventilation Other: Hypertonic saline Phase 3

Detailed Description:

An important mechanism of death in children with cerebral malaria is diffuse cerebral swelling, cerebral herniation, compression of the brainstem respiratory center, and respiratory arrest. In those who survive their illness without specific interventions, reversal of diffuse cerebral swelling is rapid.

Mechanical ventilation may help to preserve life while diffuse brain swelling diminishes. Intravenous hypertonic saline may work as an osmotic diuretic, directly decreasing brain swelling.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to one of three study arms.
Masking: Single (Outcomes Assessor)
Masking Description: Investigators assessing outcome will be blinded to the arm to which the participant was randomly assigned
Primary Purpose: Treatment
Official Title: Treating Brain Swelling in Pediatric Cerebral Malaria
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
No Intervention: Unual care
Hospitalization in a high dependency pediatric unit with skilled nursing, intravenous artesunate followed by oral artemisinin combination therapy, intravenous fluids, nasogastric feeding, elevation of the head of the bed by 30 degrees
Experimental: Mechanical ventilation
Hospitalization in a high dependency pediatric unit with skilled nursing, intravenous artesunate followed by oral artemisinin combination therapy, intravenous fluids, nasogastric feeding, elevation of the head of the bed by 30 degrees, along with intubation and mechanical ventilation for a maximum of 7 days
Other: Mechanical ventilation
Intubation and mechanical ventilation for a maximum of 7 days

Experimental: Hypertonic saline
Hospitalization in a high dependency pediatric unit with skilled nursing, intravenous artesunate followed by oral artemisinin combination therapy, intravenous fluids, nasogastric feeding, elevation of the head of the bed by 30 degrees, along with intravenous 3% hypertonic saline for a maximum of 7 days
Other: Hypertonic saline
Intravenous 3 percent hypertonic saline for a maximum of 7 days




Primary Outcome Measures :
  1. Mortality [ Time Frame: Within 7 days of randomization ]
    Alive or dead


Secondary Outcome Measures :
  1. Neurodevelopmental disability [ Time Frame: 1 year ]
    Presence and severity of neurodevelopmental disability in survivors



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Peripheral P. falciparum parasitemia of any density
  • Blantyre Coma Score ≤2
  • No evidence of meningitis on lumbar puncture
  • Consciousness not regained after correction of hypoglycemia (if hypoglycemia is present)
  • Male or female whose age on the day of screening is between 6 months and 12 years old
  • Severely increased brain volume on magnetic resonance imaging
  • Provision of consent by guardian
  • Willingness to return for 1, 3, 6, and 12 month post-randomization follow-up visits

Exclusion Criteria:

  • Gross malnutrition as evidenced by peripheral edema, hair color changes, or severe wasting
  • Advanced Human Immunodeficiency Virus (HIV) disease - defined as known HIV positive status and evidence of severe wasting
  • Evidence of recent head trauma by history or physical examination
  • Pneumonia as evidenced by oxygen saturation on room air of <85%
  • Gastroenteritis and shock as evidenced by capillary refill >3 seconds or skin tenting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300648


Contacts
Layout table for location contacts
Contact: Terrie E Taylor, DO 231-883-5948 ttmalawi@msu.edu
Contact: Douglas G Postels, MD 505-256-4929 dpostels@childrensnational.org

Locations
Layout table for location information
Malawi
Queen Elizabeth Central Hospital Recruiting
Blantyre, Malawi
Contact: Terrie E Taylor, DO    +265 999 96 92 20    ttmalawi@msu.edu   
Contact: Douglas G Postels, MD    505-256-4929    dpostels@childrensnational.org   
Sponsors and Collaborators
Michigan State University
Washington University School of Medicine
University of Maryland, College Park
Children's Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Terrie E Taylor, DO Michigan State University

Layout table for additonal information
Responsible Party: Terrie Taylor, Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT03300648     History of Changes
Other Study ID Numbers: TBS
U01AI126610 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual participant data may be made available to other researchers
Time Frame: Starting 6 months after publication

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Terrie Taylor, Michigan State University:
coma
pediatrics
Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Malaria, Cerebral
Brain Edema
Protozoan Infections
Parasitic Diseases
Central Nervous System Protozoal Infections
Central Nervous System Parasitic Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases