A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria
27 mai 2014 mis à jour par: Pfizer
A Phase 2, Open Label, Non-Comparative Trial Of Azithromycin 2000 mg Plus Chloroquine 600 Mg Base Daily For Three Days For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria
The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
110
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Males and females greater then or equal to the age of 18 with uncomplicated, symptomatic malaria as indicated by the presence of blood smears positive for P. falciparum asexual parasitemia between 1000-100,000 parasites/uL and documented fever greater then or equal to 38.5 C/101.3 F rectal or fever greater then or equal to 38 C/100.4 F oral or history of fever as reported by subject within the prior 24 hours.
Exclusion Criteria:
- Subjects with severe or complicated malaria. Pregnant or breast feeding women.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Azithromycin plus chloroquine
Single Arm, Open label study
|
dose of 2000 mg Azithromycin plus 600 mg chloroquine base
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants With Parasite Clearance at Day 28
Délai: Day 28
|
Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28.
Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance.
Percentage of participants with clearance is reported.
Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.
|
Day 28
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants With Early Treatment Failures (ETF)
Délai: Baseline up to Day 28
|
ETF was defined as a participant meeting any of these criteria: development of signs of severe malaria (impaired consciousness [for example, obtundation, unarousable coma, delirium, stupor], respiratory distress [respiratory rate greater than or equal to {>=} 30 breaths/minute], seizures, hypoglycemia [glucose less than or equal to {<=} 40 milligram/deciliter], gross hematuria, increase in parasitemia to greater than 100,000 parasites/microliter in 48 hours or later after the first treatment dose was administered) any day from Day 0 to 3 in the presence of P falciparum parasitemia; parasite count on Day 2 > Day 0 (baseline), irrespective of axillary or oral temperature; parasite count on Day 3 > 37.5 degrees Celsius (axillary temperature) and >38 degrees Celsius (oral temperature) and parasite count on Day 3 >=25 percent (%) of the first available parasite density on Day 0 (baseline).
|
Baseline up to Day 28
|
|
Percentage of Participants With Late Treatment Failures (LTF)
Délai: Baseline up to Day 28
|
LTF included late clinical failure (LCF) and late parasitologic failure (LPF).
LCF is defined as a participant meeting any of these criteria: development of signs or symptoms of severe malaria after Day 3 in the presence of P falciparum parasitemia, without previously meeting any of the criteria of ETF or presence of P falciparum parasitemia and fever or history of fever on any day from Day 4 to Day 28, without previously meeting any of the criteria of ETF.
LPF is defined as presence of P falciparum parasitemia on any day from Day 7 to Day 28 and the absence of fever or history of fever without previously meeting any of the criteria of ETF or LCF.
|
Baseline up to Day 28
|
|
Percentage of Participants With Resistance to Treatment
Délai: Days 7, 14, 21, 28, 35, 42
|
Resistance is measured by clearance of asexual P falciparum parasitemia and categorized into 3 levels; resistance I (RI): clearance of asexual P. falciparum parasitemia before Day 7 followed by recurrence on or after Day 7, resistance II (RII): marked reduction (<=25% of baseline) of asexual P. falciparum parasitemia but no clearance prior to and up to Day 7, and resistance III (RIII): no marked reduction (>25% of baseline) of asexual P. falciparum parasitemia.
Recurrence was defined as the reappearance of asexual P. falciparum parasitemia following a quiescent or latent period after the cessation of the primary attack.
Percentage of participants with resistance as measured by RI, RII and RIII is reported.
|
Days 7, 14, 21, 28, 35, 42
|
|
Percentage of Participants With Clinical Cure
Délai: Day 3, 7, 28, and 42
|
Clinical Cure is defined as resolution of the participant's fever and other symptoms attributed to P falciparum malaria (for example, abdominal pain, malaise, and headache).
|
Day 3, 7, 28, and 42
|
|
Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42
Délai: Day 7, 14, 21, 35, 42
|
Parasite clearance was defined as the clearance of asexual Plasmodium falciparum (P falciparum) parasitemia (defined as three consecutive 0 parasite counts) within 7 days of initiation of treatment, without subsequent recrudescence up to Day 28.
Failure to achieve clearance of asexual P falciparum parasitemia was defined as parasitemia not cleared within 7 days of initiation of treatment, or subsequent recrudescence (confirmed by molecular testing) by Day 28 after achieving clearance.
Percentage of participants with clearance is reported.
Here "N" (Number of participants analyzed) signify participants who were evaluable (parasitological per protocol) at Day 28.
|
Day 7, 14, 21, 35, 42
|
|
Percentage of Participants With Gametocyte Clearance
Délai: Day 7, 14, 21, 28, 35, 42
|
Gametocyte clearance was defined as clearance of P falciparum gametocytemia (defined as attainment of 3 consecutive 0 gametocyte counts) without subsequent recurrence through the day of consideration.
Recurrence was defined as the reappearance of asexual P. falciparum gametocytemia after achieving clearance.
Percentage of participants with gametocyte clearance were reported.
|
Day 7, 14, 21, 28, 35, 42
|
|
Fever Clearance Time
Délai: Baseline up to Day 42
|
Fever clearance time (FCT) was defined as the time from baseline to the first of 2 consecutive time points with temperature less than (<) 37.5 degree Celsius (C) (axillary temperature) or <38 degree C (oral temperature).
|
Baseline up to Day 42
|
|
Parasite Clearance Time
Délai: Baseline up to Day 42
|
Asexual P falciparum parasite clearance time was defined as the time from baseline to the first of the 3 consecutive 0 parasite counts.
|
Baseline up to Day 42
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2006
Achèvement primaire (Réel)
1 février 2008
Achèvement de l'étude (Réel)
1 février 2008
Dates d'inscription aux études
Première soumission
26 janvier 2006
Première soumission répondant aux critères de contrôle qualité
26 janvier 2006
Première publication (Estimation)
27 janvier 2006
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
26 juin 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 mai 2014
Dernière vérification
1 mai 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- A0661154
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