Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Malaria Clinical Trials Center General Screening (GS)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02119312
Recruitment Status : Suspended (COVID19 safety measures-institutional policy to suspend non-covid related studies)
First Posted : April 21, 2014
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date April 16, 2014
First Posted Date April 21, 2014
Last Update Posted Date June 16, 2020
Study Start Date June 2010
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2014)
Participant Enrollment [ Time Frame: Once upon enrollment ]
See inclusion/exclusion criteria.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Malaria Clinical Trials Center General Screening
Official Title General Screening for Eligibility to Participate in Treatment, Prevention and Vaccine Trials at the Seattle Malaria Clinical Trials Center
Brief Summary The purpose of this study is to identify and screen potential subjects for preliminary eligibility to participate in a malaria related clinical trial conducted at the Seattle Malaria Clinical Trials Center (Seattle MCTC) or one of our partnering sites.
Detailed Description

This is a continuous study enrolling approximately 350 participants per year to establish preliminary eligibility for participation in ongoing or future Seattle Malaria Clinical Trials Center (Seattle MCTC) clinical research studies. Data collected may be used to support preliminary eligibility for a current or future Seattle MCTC clinical research study.

In order to maximize efficiency of the screening process potential participants who contact the site will be pre-screened using an IRB-approved screening form.

Potential participants who contact the site may be asked to come in for an in-person screening visit. They will be given a consent form to read and sign if they should choose to participate in the screening process. If they have any questions during this process research staff will be available. This visit includes an in-depth medical history review, travel history, physical exam, blood draw, electrocardiogram test (ECG), and a urine test.

The Seattle Malaria Clinical Trials Center (Seattle MCTC) is conducting research to combat malaria. Malaria is a disease that is transmitted to humans by the bite of an infected mosquito and affects millions of people worldwide. Malaria can cause a wide range of medical problems, and may even result in death if the infection is not treated. Currently there are many medications, preventative measures and malaria vaccines being developed to fight malaria that will need to be tested before they can be made available to the general public. The Seattle MCTC is conducting clinical research studies for this purpose and is in need of healthy adult volunteers to take part in upcoming studies.

Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Men and non-pregnant women who are in general good health.
Condition Malaria
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: April 17, 2014)
3500
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 14, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Good general health status as demonstrated by medical history, physical exam, and screening laboratory tests;
  • No history of certain chronic medical illnesses (e.g. diabetes, epilepsy, autoimmune disease, hepatitis, heart disease);
  • HIV, Hepatitis B and C negative;
  • Low risk for coronary heart disease;
  • Ability and willingness to provide informed consent;
  • Reliable access to the MCTC and associated sites; and
  • If participant is biologically female she must not be pregnant and must agree to consistently use an effective form of birth control 21 days prior to enrollment in an active clinical study and for the duration of that study.

Exclusion Criteria:

  • Prior receipt of an investigational malaria vaccine;
  • Chronic use of systemic antibiotics or immunosuppressive medications with anti-malarial effects;
  • Chronic medical condition, physical examination findings, other clinically significant abnormal laboratory results, or past medical history that may have clinically significant implications for current health status;
  • History of systemic anaphylaxis;
  • History of, or known active cardiac disease;
  • Elevated (moderate of high) risk of coronary heart disease;
  • Clinically significant ECG findings;
  • Chronic or active neurological disease;
  • History of splenectomy or functional asplenia;
  • History of psoriasis or porphyria;
  • History of diagnosed ocular disease;
  • Positive history of HIV, Hepatitis B and/or C;
  • Pregnant or lactating females or females who intend to become pregnant during study period;
  • Certain psychiatric conditions that could affect study compliance; and
  • Suspected or known current alcohol and/or drug abuse.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02119312
Other Study ID Numbers MC-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Fred Hutchinson Cancer Research Center
Study Sponsor Fred Hutchinson Cancer Research Center
Collaborators Not Provided
Investigators
Principal Investigator: James G Kublin, MD Fred Hutchinson Cancer Research Center
PRS Account Fred Hutchinson Cancer Research Center
Verification Date June 2020