Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Azithromycin, azithromycin (Zithromax), azithromycin (AZ), azithromycin SR
Azithromycin and Chloroquine · 25 trials · 22 indications
Mortality rate (deaths per 1,000 years at risk) among children 1-11 months of age.
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100. The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
Cure=Signs\&symptoms(S\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\&S of acute infection persisted/worsened,new clinical S\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub
ACPR (PCR-corrected) was defined as asexual Plasmodium falciparum (P.falciparum) parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of Early Treatment Failure (ETF) (see measure description in secondary outcome measures 7 and 8) or PCR-corrected Late Treatment Failure (LTF) (which includes PCR-corrected Late Clinical Failures \[LCF\] - see measure description in secondary outcome measure 9 and 10, and PCR-corrected Late Parasitologic Failures (LPF)- see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.
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.
| Arm | Type | Description |
|---|---|---|
| Control | PLACEBO_COMPARATOR | Placebo mixture will be administered as a single dose in oral suspension form for children 1-11 months of age: 1. Single-dose of 0.5 ml / kg child weight 2. Participating households within villages allocated to this group will be visited quarterly (at 3-month intervals), for nine times. At the first eight of these visits, 1-11 month old eligible infants, for whom there is a consent for study drug provision, will be weighed and given a single dose of placebo mixture. |
| Azithromycin-biannually (Azi-biannual) | ACTIVE_COMPARATOR | Azithromycin or placebo will be administered as a single dose in oral suspension form for children 1-11 months of age: 1. Single-dose of 0.5 ml / kg child weight 2. Participating households within villages allocated to this group will be visited quarterly (at 3-month intervals), for nine times. At the first eight of these visits, 1-11 month old eligible infants, for whom there is a consent for study drug provision, will be weighed and given a single dose of study drug. 3. Azithromycin will be given at quarterly visits between January and June, and Placebo mixture will be given at quarterly visits between July and December. Azithromycin dose will be 20 mg / kg. |
| Azithromycin-quarterly | ACTIVE_COMPARATOR | Azithromycin will be administered as a single dose in oral suspension form for children 1-11 months of age: 1. Single-dose of 0.5 ml (20 mg) / kg child weight. 2. Participating households within villages allocated to this group will be visited quarterly (at 3-month intervals), for nine times. At the first eight of these visits, 1-11 month old eligible infants, for whom there is a consent for study drug provision, will be weighed and given a single dose of azithromycin. |
| Azithromycin switch therapy (switch from intravenous to oral). | EXPERIMENTAL | - |
| Azithromycin | EXPERIMENTAL | Azithromycin switch therapy (switch from intravenous to oral) |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| Group 2 | ACTIVE_COMPARATOR | - |
| Group 1 | ACTIVE_COMPARATOR | - |
| Azithromycin plus chloroquine | EXPERIMENTAL | Single Arm, Open label study |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo mixture will be administered as a single dose in oral suspension form for children 1-11 months of age. Weight-based dosing will be used: single-dose of 0.5 ml / kg child weight. |
| Azithromycin | DRUG | Azithromycin will be administered as a single dose in oral suspension form for children 1-11 months of age. Weight-based dosing will be used: single-dose of 0.5 ml (20 mg) / kg child weight. |
| Azithromycin plus Chloroquine | DRUG | Azithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2) |
| Mefloquine | DRUG | Mefloquine 1250 mg PO given as a split dose (750 mg \[three 250 mg capsules\]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0 |
| Azithromycin SR | DRUG | - |
| Moxifloxacin Placebo | OTHER | 1 capsule once daily for 5 days |
| Moxifloxacin | DRUG | 1 X 400mg capsule once daily for 5 days |
| Azithromycin SR Placebo | OTHER | single dose, oral. |
| amoxicillin | DRUG | 10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours |
| clarithromycin extended release (ER) | DRUG | 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily |
| azithromycin SR (Zithromax; compound: CP-62,993) | DRUG | azithromycin 2.0 g by mouth in the form of a slurry for 1 dose |
| levofloxacin | DRUG | 500 mg (two 250 mg capsules) by mouth once daily for 7 days |
| azithromycin (Zithromax) | DRUG | azithromycin 500 mg tablet by mouth once daily for 3 days |
| amoxicillin/clavulanate postassium (Augmentin ES-600) | DRUG | amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days |
| Amoxicillin/clavulinic acid | DRUG | amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days |
| Ethambutol hydrochloride | DRUG | - |
| Clarithromycin | DRUG | - |
| Rifabutin | DRUG | - |
| Fluconazole | DRUG | - |
| Artemether-lumefantrine | DRUG | Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2) |
| Azithromycin/Chloroquine | DRUG | - |
| Atovaquone/Proguanil | DRUG | - |
| Sulfadoxine-Pyrimethamine/Chloroquine | DRUG | - |
| Pyrimethamine | DRUG | - |
| Leucovorin calcium | DRUG | - |
Inclusion Criteria: On a cluster (village) level: 1. Location within Kayes, Kita, or Koulikoro region of Mali 2. Considered accessible and safe by the local health authorities and research team 3. Considered non-urban by the local health authorities and research team 4. Permission from community l...
Azithromycin and chloroquine is a combination treatment studied for uncomplicated Plasmodium falciparum malaria. Azithromycin is also studied across bacterial infections including acute bronchitis, acute otitis media, chronic bronchitis, and community acquired pneumonia. The combination pairs azithromycin with chloroquine specifically for malaria.
Pfizer, Inc. (ticker PFE) is the developer of azithromycin and chloroquine. Pfizer is also the sponsor behind the azithromycin clinical program, including the combination trial of azithromycin plus chloroquine in children with uncomplicated P. falciparum malaria in Africa.
The azithromycin plus chloroquine combination has been studied in Phase 2 for uncomplicated P. falciparum malaria. Azithromycin itself has been studied in Phase 3 trials across several indications. The combination is investigational and is not approved for malaria treatment.
The combination was evaluated in NCT00677833, a Phase 2 trial comparing azithromycin plus chloroquine with artemether-lumefantrine for uncomplicated P. falciparum malaria in children across Burkina Faso, Cote d'Ivoire, Ghana, Kenya, and Mali. That trial is completed. Azithromycin has also been studied in Phase 3 trials including NCT04424511, NCT00871494, and NCT00809328.
No. Azithromycin and chloroquine is a combination of two drugs, while Zithromax is a brand name for azithromycin alone. Azithromycin is also known as AZ, azithromycin SR, and by the compound designation CP-62,993. The combination is distinct from azithromycin monotherapy.
Azithromycin is a small molecule antibiotic developed by Pfizer, Inc. (ticker PFE). It has been studied in Phase 3 trials for acute bronchitis, acute otitis media, chronic bronchitis, community acquired pneumonia, pelvic inflammatory disease, and other bacterial infections, and in combination with chloroquine for falciparum malaria.