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Driving Reduced AIDS-associated Meningo-encephalitis Mortality (DREAMM)

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ClinicalTrials.gov Identifier: NCT03226379
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : January 17, 2019
Sponsor:
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP)
National Institute for Medical Research, Tanzania
University of North Carolina Project-Malawi (UNC Project)
French National Agency for Research on AIDS and Viral Hepatitis
Yaounde Central Hospital
Institut Pasteur
Information provided by (Responsible Party):
St George's, University of London

Brief Summary:
The DREAMM project is investigating whether point of care tests within a diagnostic and treatment algorithm together with support and additional training of laboratory and clinical staff will reduce two and ten week all-cause mortality of HIV-associated meningo-encephalitis in LMICs.

Condition or disease
AIDS-Related Opportunistic Infections Meningoencephalitis Cryptococcal Meningitis

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Other
Time Perspective: Other
Official Title: Integrating the Diagnosis and Management of HIV-associated Central Nervous System (CNS) Infections Into Routine Health Services in Low and Middle Income Countries (LMICs)
Actual Study Start Date : April 23, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 2 weeks from enrolment ]
  2. All-cause mortality [ Time Frame: 10 weeks from enrolment ]

Secondary Outcome Measures :
  1. Time to lumbar puncture (LP) or other appropriate diagnostic investigation. [ Time Frame: Up to 2 weeks from enrolment ]
  2. Time to meningo-encephalitis treatment [ Time Frame: Up to 10 weeks from enrolment ]
    Treatment can be anti-fungal, antibiotic, antiviral, or anti-parasitic based on confirmed microbiological diagnosis

  3. Number of patients diagnosed with cryptococcal meningitis [ Time Frame: 10 weeks from enrolment ]
  4. Number of patients diagnosed with tuberculous meningitis [ Time Frame: 10 weeks from enrolment ]
  5. Number of patients diagnosed with toxoplasma meningo-encephalitis [ Time Frame: 10 weeks from enrolment ]
  6. Number of patients diagnosed with bacterial meningitis [ Time Frame: 10 weeks from enrolment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study will be conducted at three sites in southern, eastern and central Sub-Saharan Africa:

  1. Amana and Mwananyamala hospitals, Dar Es Salaam, Tanzania
  2. Kamuzu Central Hospital (KCH), Lilongwe, Malawi
  3. Hôpital Central Yaoundé (HCY), Yaoundé, Cameroon

Adult HIV positive patients presenting to hospital at DREAMM study sites with a first episode of suspected meningo-encephalitis will be eligible for the study.

In the context of HIV, patients with headache, and/or seizure, and/or reduced level of consciousness/abnormal behaviour and/or focal neurology require investigation for meningo-encephalitis.

Criteria

Inclusion Criteria:

  1. Consecutive patients > 18 years with 1st episode of suspected meningo- encephalitis
  2. Known to be HIV positive or willing to undertake an HIV test
  3. Willing to agree to participate in the study

Exclusion Criteria:

  1. Patients presenting with suspected relapse of HIV-associated meningo-encephalitis
  2. Cerebral malaria confirmed on point of care test or thick/thin blood film, by clinical evaluation and further investigation, as required
  3. HIV negative patients
  4. Pregnant or lactating patients

Patients who are HIV negative or are diagnosed with cerebral malaria on hospital admission or after initial investigation will be excluded or withdrawn from the DREAMM study.


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): NCT03226379


Contacts
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Contact: Angela Loyse, MD 020 8725 0443 aloyse@sgul.ac.uk

Locations
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Malawi
Kamuzu Central Hospital Recruiting
Lilongwe, Malawi
Contact: Cecilia Kanyama, MD         
Tanzania
Amana Hospital Recruiting
Dar es Salaam, Tanzania
Contact: Sayoki Mfinanga, MD         
Sponsors and Collaborators
St George's, University of London
European and Developing Countries Clinical Trials Partnership (EDCTP)
National Institute for Medical Research, Tanzania
University of North Carolina Project-Malawi (UNC Project)
French National Agency for Research on AIDS and Viral Hepatitis
Yaounde Central Hospital
Institut Pasteur
Investigators
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Principal Investigator: Angela Loyse, MD St George's, University of London

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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT03226379     History of Changes
Other Study ID Numbers: 16.0091
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Meningitis
Opportunistic Infections
AIDS-Related Opportunistic Infections
Meningitis, Cryptococcal
Meningoencephalitis
Central Nervous System Diseases
Nervous System Diseases
Virus Diseases
Parasitic Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
Mycoses
Cryptococcosis
Central Nervous System Infections
Encephalitis
Brain Diseases
Central Nervous System Viral Diseases