- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00401557
Mechanisms Relating to the Distinct in Vitro Susceptibility of Human Macrophages to L. Viannia Infection
Intervenable Host - Leishmania (Viannia) Interactions - Project 3: Immune and Inflammatory Responses in L. (Viannia) Infection - Aim 3: Mechanisms Relating to the Distinct in Vitro Susceptibility of Human Macrophages to L. Viannia Infection
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Cali, Kolumbien
- Centro Internacional de Entrenamiento e Investigaciones Medicas, CIDEIM
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Historical cases of chronic disease:
- Age between 18-70 years
- Historic parasitologically confirmed, skin test positive cutaneous leishmaniasis (CL) patients who presented chronic CL lesions of > 6 months duration at the time of diagnosis
- No active lesions
Historical cases of recurrent disease:
- Age between 18-70 years
- Historic CL patients who have developed new parasitologically confirmed lesions after resolution of prior disease
- No active lesions
Asymptomatic infection:
- Age between 18-70 years
- Resident of endemic area
- No history or evidence of active or prior dermal leishmaniasis
Healthy donors:
- Age between 18-70 years
- No history or evidence of exposure to transmission of leishmaniasis
Beschreibung
Inclusion Criteria:
For specific objectives 1, 3 and 4:
Historical cases of chronic disease:
- Age between 18-70 years
- Historic parasitologically confirmed, skin test positive cutaneous leishmaniasis (CL) patients who presented chronic CL lesions of > 6 months duration at the time of diagnosis
- No active lesions
- Voluntary participation in the study
- Written and signed Informed consent for HIV testing and participation in the study
Historical cases of recurrent disease:
- Age between 18-70 years
- Historic CL patients who have developed new parasitologically confirmed lesions after resolution of prior disease
- No active lesions
- Voluntary participation in the study
- Written and signed Informed consent for HIV testing and participation in the study
Asymptomatic infection:
- Age between 18-70 years
- Resident of endemic area
- No history or evidence of active or prior dermal leishmaniasis
- Voluntary participation
- Written and signed Informed consent for HIV testing and participation in the study
Healthy donors:
- Age between 18-70 years
- No history or evidence of exposure to transmission of leishmaniasis
- Voluntary participation
- Written and signed Informed consent for HIV testing and participation in the study
For specific objective 2:
Historical cases of chronic disease:
- Age between 18-70 years
- Historic parasitologically confirmed, skin test positive CL patients who presented chronic CL lesions of > 6 months duration at the time of diagnosis
- No active lesions
- Voluntary participation in the study
- Written and signed Informed consent for HIV testing and participation in the study
Historical cases of recurrent disease:
- Age between 18-70 years
- Historic CL patients who have developed new parasitologically confirmed lesions after resolution of prior disease
- No active lesions
- Voluntary participation in the study
- Written and signed Informed consent for HIV testing and participation in the study
Asymptomatic infection:
- Age between 18-70 years
- Resident of endemic area
- No history or evidence of active or prior dermal leishmaniasis
- Voluntary participation
- Written and signed Informed consent for HIV testing and participation in the study
Healthy donors:
- Age between 18-70 years
- No history or evidence of exposure to transmission of leishmaniasis
- Voluntary participation
- Written and signed Informed consent for HIV testing and participation in the study
Exclusion Criteria:
Exclusion criteria for all groups (for specific objectives 1, 3 and 4):
- Immunosuppressive disease
- Pharmacotherapy with drugs that are immunosuppressive
- Pregnancy
- Breastfeeding
- Unwillingness to participate
Exclusion criteria for all groups (for specific objective 2):
- Weight below 50kg
- Immunosuppressive disease (HIV)
- Treatment with drugs that are immunosuppressive
- Pregnancy
- Breastfeeding
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Nancy Saravia, Ph.D., Centro Internacional de Entrenamiento e Investigaciones Médicas
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 0608001740
- U19AI065866 (US NIH Stipendium/Vertrag)
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