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

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.

Time frame: Day 28

Population: Parasitological per protocol (PP) population: Participants who had study drug for 3 days unless treatment failure, no concomitant anti-malarial unless designated treatment failure, had test of cure at Day 28, baseline smear with parasitemia between 1000-100000 parasites/microliter, rapid diagnostic test positive for P falciparum, history of fever.

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).

Time frame: Baseline up to Day 42

Population: Data not possible to report, as clearance time was obtained as life table plots only, as per planned analysis.

Asexual P falciparum parasite clearance time was defined as the time from baseline to the first of the 3 consecutive 0 parasite counts.

Time frame: Baseline up to Day 42

Population: Data not possible to report, as clearance time was obtained as life table plots only, as per planned analysis.

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).

Time frame: Day 3, 7, 28, and 42

Population: Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure.

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).

Time frame: Baseline up to Day 28

Population: Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure.

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.

Time frame: Day 7, 14, 21, 28, 35, 42

Population: Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point.

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.

Time frame: Baseline up to Day 28

Population: Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure.

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.

Time frame: Day 7, 14, 21, 35, 42

Population: Parasitologic PP population. Here, N (Number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point.

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.

Time frame: Days 7, 14, 21, 28, 35, 42

Population: Parasitologic PP population. Here, N (Number of participants analyzed) signifies those who were evaluable for this outcome measure and n signifies number of participants who were evaluated at given time point.