A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00282919
First received: January 26, 2006
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.


Condition Intervention Phase
Falciparum Malaria
Drug: Azithromycin plus chloroquine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Parasite Clearance at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Early Treatment Failures (ETF) [ Time Frame: Baseline up to Day 28 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Late Treatment Failures (LTF) [ Time Frame: Baseline up to Day 28 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Resistance to Treatment [ Time Frame: Days 7, 14, 21, 28, 35, 42 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Clinical Cure [ Time Frame: Day 3, 7, 28, and 42 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Parasite Clearance at Day 7, 14, 21, 35, 42 [ Time Frame: Day 7, 14, 21, 35, 42 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Gametocyte Clearance [ Time Frame: Day 7, 14, 21, 28, 35, 42 ] [ Designated as safety issue: No ]
    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.

  • Fever Clearance Time [ Time Frame: Baseline up to Day 42 ] [ Designated as safety issue: No ]
    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).

  • Parasite Clearance Time [ Time Frame: Baseline up to Day 42 ] [ Designated as safety issue: No ]
    Asexual P falciparum parasite clearance time was defined as the time from baseline to the first of the 3 consecutive 0 parasite counts.


Enrollment: 110
Study Start Date: March 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azithromycin plus chloroquine
Single Arm, Open label study
Drug: Azithromycin plus chloroquine
dose of 2000 mg Azithromycin plus 600 mg chloroquine base

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282919

Locations
Colombia
Pfizer Investigational Site
San Andres de Tumaco, Narino, Colombia
India
Pfizer Investigational Site
Bambolim, Goa, India, 403002
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00282919     History of Changes
Other Study ID Numbers: A0661154
Study First Received: January 26, 2006
Results First Received: May 27, 2014
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Azithromycin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics
Central Nervous System Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014