Clinical Trial: Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: An Open Label, Non-comparative Study To Evaluate Parasitological Clearance Rates And Pharmacokinetics Of Azithromycin And Chloroquine Following Administration Of A Fixed Dose Combination Of Azithromyc

Brief Summary: The study will be conducted in asymptomatic pregnant women with P. falciparum parasitemia. The subjects will be given 3 day dosing regiment of the fixed-dose combination of Azithromycin and Chloroquine. Parasitological clearance rate with polymerase chain reaction data will be evaluated on Day 28 as primary endpoint.

Detailed Summary: After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.
Sponsor: Pfizer

Current Primary Outcome:

• Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication [ Time Frame: Day 28 ]
  The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.
• Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication [ Time Frame: Day 28 ]
  The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.

Original Primary Outcome: Parasitological response (PCR corrected) at Day 28 post first dose of study medication. [ Time Frame: Day 28 ]

Current Secondary Outcome:

• Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication [ Time Frame: Days 7, 14, 21, 35, and 42 ]
  The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.
• Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication [ Time Frame: Days 7, 14, 21, 35, and 42 ]
  The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.
• Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication [ Time Frame: Days 7, 14, 21, 28, 35, and 42 ]
  The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.
• Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication [ Time Frame: Days 7, 14, 21, 28, 35, and 42 ]
  The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.
• Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication [ Time Frame: Days 7, 14, 21, 28, 35, and 42 ]
  Parasite counts (actual counts per microliter of blood) was measured at various time points.

Original Secondary Outcome:

• Parasitological responses (PCR corrected) [ Time Frame: Day 7 ]
• Parasitological responses (PCR corrected) [ Time Frame: Day 14 ]
• Parasitological responses (PCR corrected) [ Time Frame: Day 21 ]
• Parasitological responses (PCR corrected) [ Time Frame: Day 35 ]
• Parasitological responses (PCR corrected) [ Time Frame: Day 42 ]
• Parasitological responses (PCR uncorrected) [ Time Frame: Day 7 ]
• Parasitological responses (PCR uncorrected) [ Time Frame: Day 14 ]
• Parasitological responses (PCR uncorrected) [ Time Frame: Day 21 ]
• Parasitological responses (PCR uncorrected) [ Time Frame: Day 28 ]
• Parasitological responses (PCR uncorrected) [ Time Frame: Day 35 ]
• Parasitological responses (PCR uncorrected) [ Time Frame: Day 42 ]
• Parasite counts at each visit - number of asexual P. falciparum parasites per microliter of blood. [ Time Frame: Day 7 ]
• Parasite counts at each visit - number of asexual P. falciparum parasites per microliter of blood. [ Time Frame: Day 14 ]
• Parasite counts at each visit - number of asexual P. falciparum parasites per microliter of blood. [ Time Frame: Day 21 ]
• Parasite counts at each visit - number of asexual P. falciparum parasites per microliter of blood. [ Time Frame: Day 28 ]
• Parasite counts at each visit - number of asexual P. falciparum parasites per microliter of blood. [ Time Frame: Day 35 ]
• Parasite counts at each visit - number of asexual P. falciparum parasites per microliter of blood. [ Time Frame: Day 42 ]

Dates:
Date Received: April 7, 2010
Date Started: March 2011
Date Completion:
Last Updated: January 22, 2015
Last Verified: January 2015